chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This case was reported by a other health professional and described the occurrence of hepatitis b virus test positive in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, several weeks after receiving Hepatitis B vaccine, the patient experienced hepatitis b virus test positive. On an unknown date, the outcome of the hepatitis b virus test positive was unknown. It was unknown if the reporter considered the hepatitis b virus test positive to be related to Hepatitis B vaccine. Additional details were received a dose of Hepatitis B vaccine. The number doses the patient received were unknown. After few weeks the patient underwent the hepatitis B vaccine test which was revealed to be positive. The reporter did not know the name of the test. Refer case US2015GSK1267616, for the details of another patient vaccinated with Hepatitis vaccine.
Redness size of baseball, pain (8 on scale 0-10, with 10 most severe), itchy. Called Health Center and advised to give 2 Benadryl q4h until resolved.  Mom did so from 12/9 4 pm through 12/10 (2 pills q4h). Gave just a few doses (per mom) 12/11, and was completely resolved by 12/13.  Missed 2 days of school.  Vomit x2 8:30 pm on 12/7 (DOA) and diarrhea x1 after Benadryl on 12/10.
Significant inflammation of the upper arm encircled by red itchy skin.  Very warm to the touch
WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SIZE OF AN HALF DOLLAR. THE LYMPH NODE ON MY RIGHT SIDE IS ALSO SWOLLEN. ON DAY 2, I HAD FLU LIKE SYMPTOMS WITH A FEVER OF 100.8 THAT SUBSIDED WITH TYLENOL. THE INJECTION SITE BECAME ITCHY ON DAY 3 AND IS STILL RED, WARM, SWOLLEN AND THE SIZE OF AN EGG AND MY LYMPH NODE IS STILL SWOLLEN AND SORE.
Pt reports fever; BLE edema; H/A - on & off with dizziness; Abdominal cramping; looses stools w/ offensive odor; fatigue started on 4/6/21
Pt developed a generalized varicella rash all over body, with no fever and two small areas of psoriasis.
My arm was sore a couple hours on the first day, the next day I woke up achy with my arm more sore. I went to work and later started feeling pain under my eyes in my sinuses where I also noticed swelling. It is now the next day (2 days after the vaccine) and the pain and swelling has not gone away.
Got AF next day and periodic drops in bp as low as 85/56 lasted over 4 weeks and then stopped. Hadn?t had AF since cardiac ablation 6 years prior.  First shot resulted in same thing but took 3 1/2 days to begin.
Extreme pain with egg-sized swelling on the 12th.  On the 13th, the pain remains, and the swelling has expanded from injection site to just above elbow on right arm. The swollen area is now red.
New erythema area on left deltoid.  Area covers most of deltoid area and is slightly warm to the touch. Patient stated he noticed it this am.
fever 101 since administration of vax vomited 5 times in 4 days, poor appetite, fussy;
Information has been received from a nurse practitioner concerning a 12 year old female who at 11:30 am on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml. Other suspect therapy included hepatitis A vaccine (inactive) (manufacturer unknown) (duration and dose not reported) and varicella virus vaccine live (Oka/Merck) (MSD) (duration and dose not reported). Other concomitant therapy included MENACTRA vaccine (dip toxoid). Within several minutes, at 11:35 am, the patient felt dizzy and bumped her head on the side of the wall (also reported as at the receptionist's desk as she was walking down the hallway and she experienced syncope. The patient stated that she did not see that she was walking into the side of the wall as she started to feel dizzy and her vision went blurry. The patient did not lose consciousness. She was observed and then was able to leave the office. The patient recovered from the fall and syncope. The patient sought medical attention in the office. Additional information is not expected.
arm was little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was little sore) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 038K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LOVASTATIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was little sore). On 05-Feb-2021, VACCINATION SITE PAIN (arm was little sore) had resolved.            No treatment medications were provided   This case was linked to MOD-2021-282847 (Patient Link).
By 2:30 she was developing a HA which continued to worsen despite lying down and taking 2 Advil.  Within an hour HA rated up to a 10 and she developed chills and nausea.  Contacted the nurse Advisor Line.  Took 12.5 mg oral benadryl and able to sleep a little.  By 7:00pm starting to improve.  Took another Advil and went to bed.  Up at 5:am this morning and feeling fine.  She reports has not gotten any flu vaccine for last 15 years when she had an injectable vaccine and 2 days later had fever and chills and malaise lasting 4 days.
I, the patient, within five seconds of the shot being administered, lost consciousness and collapsed. For about twenty minutes after I regained consciousness, I felt flushed, woozy, and had difficulty focusing my vision.
Patient said her lymph nodes under her arms became swollen for a couple of days after her booster. This did not happen with her first 2 doses, so she wanted to report it.
Expired product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-July-2021 content no new information
She have hives and it is now all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She have hives and it is now all over her body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (She have hives and it is now all over her body). At the time of the report, URTICARIA (She have hives and it is now all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment activities for event was done with zyrtec..
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unspecified date the patient was inadvertently vaccinated with an expire dose of ZOSTAVAX, (lot# and dose were not provided). No adverse effect was reported. Additional information has been requested.
Following day muscle & joint pain, chills, redness and warmth to touch injection site. No fever. Was better next day and better yet day three
Patient had an anaphylactic reactions. Her symptoms were red bump and swelling on parts of her body. Patient is currently using BENADRYL.
On 12/30/2020 complained of stomach pain and insisted he be transferred to the hospital.  He experienced no significant physical or long-term outcome and was returned to the facility without incident.  I am reporting because he was transferred to the hospital within three days following the vaccine.
Hives appeared on upper chest and breast area, and on lower middle back approximately 27 hours after receiving both the influenza and pneumonia vaccines.
Severe muscle pain , headache , loss of appetite and foggy brain , hard to walk and turn over in bed due to muscle and all over body pain . This lasted for two solid days and after slowly started to subside . After 5 days a little slow getting better
pt had temp of 104 approx 1 1/2 - 2hr p/vax;pt was seen in ER & given APAP;fever resolved & did not return;
Symptomatic since 12/20/21, Positive Covid Test on 12/21/21. Isolation for 10 days until 12/30/21. Infection control aware. Antibody testing ordered.
Pain from her elbow to her wrist; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from her elbow to her wrist) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain from her elbow to her wrist) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain from her elbow to her wrist) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Email address was updated, all event outcome was updated from unknown to recovered.
HAVING SYMPTOMS OF COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced having symptoms of covid after receiving the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having symptoms of covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150229.
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 25-FEB-2017, the patient received an expired dose of ZOSTAVAX vial 19400 plaque forming units (PFU) (lot # L046293 with expiration date 17-FEB-2017, 0.65 ml, once, subcutaneous (SQ)) for prophylaxis. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
The 29 year old patient has never had any back or spine issues or pain reported.    The patient was mandated/ force to get the Moderna shot. The second dose of Moderna was given on 12/7/2021. On day 5 which was 12/12/2021 he reported he woke up that morning and has small back pain. He said he has tried heating pads, back brace and ibuprofen 800 mg. Nothing seems to work.   On 12/21/2021, the patient was seen at the ER room. The patient states that the lower and upper spine hurts and the pain has gotten to a level 10 and seems to be getting worse each day. The ER, doctor did a CT SCAN that shows small multilevel marginal osteophytes in the spine, Facet hypertrophic change of the lower and upper lumbar spine. Possible Small disc protrusions of the mid and lower lumbar spine.  Also a mild bilateral foraminal narrowing of the mid and lower lumbar spine. Also showed scatted colonic diverticula and a kidney stone on the mid pole of left kidney.   The patient sense this date has had tingling in the right arm and right leg. Also has reported sharp shooting pain from back legs to knee cap every so often. Also reports feeling weak. The pain gets so bad the patient starts shaking and blood pressure goes up as well. The patient never had high blood pressure till the second shot and pain started.   The patient was started with physical therapy on 1/13/2022 and is still going to this day. The patient reports that when they press on his spine it feels amazing and relives the pain. Sense then we have gotten the patient from being in pain in the lower spine all the time to only hurts when he is moving around for a bit or bending.    On 1/19/2021 the patient was seen by pain management. The patient was put on gabapentin 200 mg  3 times a day and a MRI and X rays where ordered. The patient had the X- rays on 1/19/2022 and the results showed nothing.  Then the patient had MRI on 1/27/2022 and the results showed nothing. The patient was seen again 0n 2/4/2022 and was started on gabapentin 300 mg 3 times a day and referred to Rehab for a Bilateral EMG, Upper And Lower Extremities because of  Lumbar Radiculopathy and Hypersensivity to vaccine containing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA.     The patient did try getting a medical exemption thru his job. But the denied his request. Also the patient has been put on a 8 hour shift only and nothing more due to the pain increasing.
Initial report received from a pharmacist on 19 November 2013. A 43 year old female patient. whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH904AA) (site of vaccination were not reported) intramuscularly on 21 September 2013. The nurse reported that patient's entire arm became sore on the same day (21 September 2013) as the vaccine was administered. Symptom has not subsided. Corrective treatment was not reported. At the time of this report the outcome of adverse event was not resolved. Documents held by sender: none.
widespread whole body macular pap blanching, red lesions noted 8/24/99;no rx given;
Pt seen on 3/12/03. Eight hours after immunization given. L thigh with erythema encompassing 1/3 ? of thigh. ? induration with violaceous coloration, warm. Started on Augumentin as possible cellulitis, however cleared in 48 hrs and did not come back for follow up. Interesting second patient came in with a similar reaction with only more in common.
No adverse event; Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.) 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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.).    No concomitant medications was reported. No treatment medications was reported.
local redness & swelling around inj site rt deltoid area 4x10cm;itching rt side of head;rx DPH & APAP for pain;
I been having high than normal blood pressure and weird pains around my heart and chest. Which lead to me going to the ER. No diagnosis but have a follow up 07/20/2021.
Third dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX).   On 28-FEB-2023, the patient received the 3rd dose of Shingrix. On 28-FEB-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Third dose administered). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 28-FEB-2023 A medical assistant called to inform that a patient received a third dose of Shingrix earlier that day.  The second dose of Shingrix had been administered on 24 February 2023.  The vaccine administration facility was the same as primary reporter. The reporter had consent to follow-up. At the time of reporting, the patient had received his third dose of Shingrix vaccine, which had led to extra dose administered.
This spontaneous report as received from the medical assistants and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature above 46F but below 77F for 3 hours) doses of RECOMBIVAX HB (lot # M037248, expiration date 21-FEB-2019; dose and route of administration were not reported) for prophylaxis. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004698: US-009507513-1702USA003256.
2 week headache and congestion; terrible fatigue and body aches. Started 1-2 weeks after nasal spray.
Information has been received from a physician concerning a patient who on an unspecified date in 2008 was inadvertently vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot# reported as 796). It was reported that the patient was intended to receive ZOSTAVAX (Merck). No adverse symptoms were reported. No further information is available.
Patient discharged. 90yo admitted with covid 19 infection, no breathing issues but generalized weakness. Her husband is ill with the same symptoms. She was placed in observation and PT/OT worked with her and recommended SAR. She was placed on keflex for questionable cellulitis of LLE and chronic wound that "got better then came back in the same spot." CRP trended and improved. Her potassium was replaced and given fluids for dehydration. Her appetite improved. CM gave her places for SAR but then pt changed her mind and did not want to go to SAR. She wanted to go home with husband also admitted. She was discharged with her husband in the same Non-Emergency Medical Transit to home with home health care. Referral for wound clinic placed at discharge. She will continue keflex to finish her course and follow up with PCP.
On December 22nd I had a tickle throat and cough and a runny nose and headache. I had a fever on and off with chills. I was extremely tired and sore all over. I tested negative that night but positive for COVID-19 the following morning. I was prescribed and began taking PAXLOVID on December 23, 2022. The symptoms began to be better within about 5 hours but the symptoms from PAXLOVID were worse and included diarrhea. As of today, my nose is a little runny, but I have not had a fever in a day and a half. My headache is very mild.