chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After shot, that Saturday, my back went out; I was having trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) and GAIT DISTURBANCE (I was having trouble walking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O31120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) and GAIT DISTURBANCE (I was having trouble walking). At the time of the report, MUSCULOSKELETAL DISCOMFORT (After shot, that Saturday, my back went out) outcome was unknown.        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.
on 3/7/04 (24 hours later) child had redness, swelling and pain at site of left deltoid DTaP injection of 3/6/04. Temp 101, down to 99 (after Motrin) At ER Dept. at hospital. Seen in ER 3/7/04, Meds prescribed Keflex Aid, Benadryl Aid
Diagnosis with deep vein thrombosis, in August he suffer DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 030l20a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included TAMSULOSIN, MELOXICAM, LEVOCETIRIZINE, MONTELUKAST, ASPIRIN [ACETYLSALICYLIC ACID], LORATADINE and VITAMINS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Diagnosis with deep vein thrombosis, in August he suffer DVT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Other concomitant medication included arthritis medicine. Patient received booster dose on 10 September 2021 with lot number 020f21a.  Company comment: This case concerns an 80-year-old male patient, with no relevant medical history reported in this case, who experienced the serious unexpected AESI of Deep vein thrombosis. The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine and the outcome was reported as Unknown.  The event was assessed with the seriousness criteria of Medically Significant although no further information on clinical course, diagnostic tests performed or required treatment was disclosed. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80-year-old male patient, with no relevant medical history reported in this case, who experienced the serious unexpected AESI of Deep vein thrombosis. The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine and the outcome was reported as Unknown.  The event was assessed with the seriousness criteria of Medically Significant although no further information on clinical course, diagnostic tests performed or required treatment was disclosed. The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I experienced mild low grade fever, like 102F and shaken chills and this has happened every single time after my vaccine.  I took some OTC Tylenol for pain. I took at home test COVID-19 test on 09/27/2022.  I developed COVID symptoms was on 09/27/2022. I experienced chills and fever lasting . I was given Paxlovid by Dr. and once I started this medication after 4-5 hours I started to feel better. I did have a metallic bitter taste in my mouth and felt tired but overall the Paxlovid helped me tremendously.
Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Arthritis, GERD, Depression, Hyperglycemia, Drug allergy (Nexium), Drug allergy (Prilosec), Drug allergy (Zantac) and Drug allergy (PCN). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Hyperglycemia, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) to be probably related.    Treatment information was not provided by the reporter.   This case was linked to MOD-2021-009888, MOD-2021-009888 (Patient Link).
The patient said the day after he felt nausea throwing up cold and hot flashes aches and pains. when he went to the er the dr said his blood pressure was elevated and gave him  bp meds. today he said his blood pressure is almost back to normal. diastolic was a little high at 90. He said other pts and dr complained of similar symptoms with flu /covid combination.
Monday 0730 am had flu shot at work (mandatory). Itching , redness, hives within 3 hours, swelling  and warmth at injection site, large area of erythema to my left upper arm by the end of my 12 hour shift .  Full body rash by midnight. Took Benadryl to be able to sleep. Worked 12 hour shift the next day after taking loratadine, but still itching, rash, erythema, body aches,  and large hives. The next day I was off, went to healthcare professional, they said to continue what I was doing, and call them on Friday (2 days later) if it wasn't any better. Friday they sent me to see the physicians, who gave me steroids, I still had the rash, itching, and hives (was RTW that day, I had been off work since Wednesday). I called off work  Saturday, worked Sunday, still had rash and itching. Monday rash and itching were gone, I was taking my 4th day of steroid treatment.
On 10/23/02, the infant received his first injections of Infanrix. On that date, he also received his first injections of Hib vaccine, (brand name unknown) and IPOL. Within four hours of immunization, he began  crying inconsolably; this persisted for approximately 2.5 hrs. He also experienced fever and irritability, which were treated with paracetamol (Tylenol). The events resolved on 10/24/01. The Infanrix immunization series was discontinued. The reporter stated that the events were moderate in severity and were possibly related to Infanrix administration.
(L) thigh localized inflammation/irritation. No temp or leg pain. Mild itching - resolved with BENADRYL. Small area of erythema persisting.
A hour after the vaccines my sons eye lids swelled up, called dr said was prob just allergies. I gave him Benadryl thru out night and next morning till the eye lids went down. Then 6 days later 3/27/2014 He gets a huge whelp on his right leg and its hot to the touch. Where he got the Vaccine. Called after hour line told not to come in but give Benadryl and follow up with Dr next day which I did.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2018 the patient was vaccinated with VARIVAX (lot #R009411 and expiration date 29-MAR-2020), subcutaneous (dose, units and frequency were unknown) despite an unspecified history of immunity (extra dose administered and circumstance or information capable of leading to medication error). The vaccine was reconstituted with sterile diluent (MERCK). No adverse effect reported. There was no product quality complaint reported.
Fainted after flu shot - was sitting in chair - nurse lowered him to floor B/P 110/60 P. 76 - spirits of Ammonia given - recovered - went back to work.
Pt received TWINRIX 1 ml IM (L) deltoid 00910. Pt c/o lightheadedness and sweating at 0925. Pt given cup of lemonade. 0935 Pt began to be SOB. 50 mg BENADRYL IM at deltoid. Albuterol breathing tx.
A nurse reported a pt  with a history of sensitivity to egg whites inadvertently received an injection of Acel-Imune on 8/28/00. She also received vaccine of PPD. Later that day she developed achy joints, profuse sweating and a feeling of being tired. The reporter indicated that the reaction was similar to the one the pt has when she eats egg whites. The pt was treated and recovered; however still had some leg discomfort now and again but felt better.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Redness and numbness of cheeks-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: After patient was given vaccine by technician, pt reported having numbness of cheeks. Temperature was then taken and showed 99.7F. Diphenhydramine 25 mg x 1 dose was given and pt was monitored for 15 more mins. Afterwards, pt no longer reported feeling numbness on sides of face, and she left on her own accord.
Pain in the back started and it was on and off. Then, two weeks after each dose, I had hives. After that, my body  never felt the same. I felt fatigue and had pain that moved through different parts of the body. I visited primary care many times but they could not figure it out what was wrong until Nov 2, 2021 that I got diagnosed with Systemic lupus erythematosus (SLE).
Patient reports that after the vaccine he felt a mild fever- did not take any antipyretics and woke up with decreased vision in the right eye. He has baseline poor vision in bilateral eyes due to known optic neuritis. The vision in the right eye has never returned to baseline. He believes it could have been from the fever he had  but he is sure that it occured after the shingrix vaccine. He has prior had the zostavax vaccine in 9/2014 without any reaction.
Td given on 11/22/04. Patient stated ok until 11/23/04 in the PM started with pain, quarter size swelling. Unable to lift arm. Pain into axilla. Advised ice pack, Tylenol for pain; Ibuprofen. Patient has appointment on 11/29/2004.
Pneumonia vaccine every 2 years; This spontaneous report was received from a consumer via Pfizer and refers to a male patient of unknown age. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD) and type II diabetes and his historical conditions included pneumonia 5 times that required hospitalization 4 times. The patients historical vaccines included shingle shot (manufacturer unknown).  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) every 2 years.  The patient subsequently experienced missed dose, product prescribing issue and dry cough while on therapy with lisinopril (manufacturer unknown) and tozinameran (COMIRNATY) (case # 2104USA006761).; Sender's Comments:  US-009507513-2104USA006761:
Soreness at injection sight right away, inflammation and swelling 18 hrs later, dizziness and general malaise within few hours; still reporting pain at sight 5 days later but no swelling.
Heart issues...rapid and strong beating...occasional light headed...I went to the ER because I almost fainted twice at work.  Now have a cardiologist.  Have had 3 EKG's, just had a 48 hour halter and an echocardiogram.  I am feeling better than I initially did, but it was 3 weeks and 1 day from the 2 dose that I started feeling better.  I'm still very winded, still have heart palpitations/feels like it beats out of sync.  But it is better.  I'm not back to normal.  Scared to do cardio activity, but I am walking.
confusion, vomiting and low grade fever; confusion, vomiting and low grade fever; confusion, vomiting and low grade fever; the emergency department physician stated that these symptoms might be related to the GARDASIL 9; This spontaneous report was received from a nurse prescriber via a company representative, referring to a 13-year-old female patient. The patient's pertinent medical history, concomitant therapies, and drug reactions or allergies were unknown by the reporter.  On 13-JUN-2019, the reporting nurse vaccinated the patient with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, concentration, vaccination scheme, frequency, route of administration, anatomical site of vaccination, lot number, and expiration date were not reported).       On 14-JUN-2019, the patient presented to the emergency department with confusion, vomiting and low grade fever (confusional state, vomiting and pyrexia). The reporter mentioned that the emergency department physician stated that these symptoms might have been related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination complication); however, the causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events above was not provided by the reporting nurse. It was unknown by the reporter if treatment was given to the patient or if laboratory diagnostics or studies were performed to the patient for these events.   At the time of reporting, the outcome of confusional state, vomiting, and pyrexia was unknown. It was reported that subsequent doses of therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not discontinued.
This spontaneous report was received from a nurse refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 17-AUG-2017, the adult patient was vaccinated with one pediatric dose of VAQTA 25/0.5 (unit unspecified) (lot # M015290, expiry date: 20-SEP-2017) (dose volume and route unspecified) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was involved.
Injected too high on shoulder. Right shoulder intermittent pain since vaccine, getting worse. I have been taking OTC Tylenol, but haven't sought other medical treatment thus far.  Unsure if the pain will persist or resolve.
Extreme headache and extreme itching all over my upper body front and back. Triggered my eczema.
Left intertrochanteric fracture of the hip. OPERATIVE PROCEDURE: Short gamma nail fixation, left hip. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
FEELING DIZZY; CLAMMY; TIGHNESS ON CHEST; NAUSEA WITHOUT VOMITING; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient has no allergies, no drug abuse or illicit drug usage. patient was non smoker and consume alcohol sometimes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and batch number: 207A21A) dose was not reported, administered on 27-MAY-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling dizzy. On 27-MAY-2021, the subject experienced clammy. On 27-MAY-2021, the subject experienced tighness on chest. On 27-MAY-2021, the subject experienced nausea without vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, clammy, nausea without vomiting, and tighness on chest. This report was non-serious.
5 months ongoing, daily abdominal pain and colorectal bleeding.   Frequent (several times weekly) uterine bleeding.
BREAKTHROUGH COVID: FULLY VACCINATED 63 YO WITH ACUTE COVID AND CHEST PAIN. PT history of CAD, cardiac stent in 2015, hypertension, hyperlipidemia who presents to the ER on July 8, 2022 for chest pain.  He was diagnosed with COVID 2 days prior at home.  He stated that he had chest pain when moving from side to side.  He denied shortness of breath but did admit to cough.  He admitted to sore throat.  He also admitted to headache.  He denied lightheadedness or dizziness.  No syncope.  No vision changes.  No numbness.  NO COVID MEDICATIONS PRESCRIBED DURING ADMISSION, ASPIRIN AND ALBUTEROL.
Pt received 4 mo - izs. PDRX - (PEDIARIX) (DTAP, IVP, HEP B) - HIB - PREVNAR - Rotavirus. In eve. pt fever 100 F - stopped breathing almost like choking. Mom picked her up and blew on her face. Lasted a few seconds. No shaking of extremities.
WBC 12.5; Lactic Acid 3.2; woke up confused (only knew names); septicemia; Flu-like symptoms; Fever (100 degrees); This serious case was reported by a consumer via call center representative and described the occurrence of septicemia in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number DJ455, expiry date 26-JAN-2024) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 19-MAY-2023, 1 days after receiving Shingrix, the patient experienced septicemia (Verbatim: septicemia) (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (Verbatim: Flu-like symptoms) (serious criteria hospitalization) and fever (Verbatim: Fever (100 degrees)) (serious criteria hospitalization). On 26-MAY-2023, the patient experienced confusion (Verbatim: woke up confused (only knew names)) (serious criteria hospitalization). On an unknown date, the patient experienced white blood cell count abnormal (Verbatim: WBC 12.5) (serious criteria hospitalization) and blood lactic acid abnormal (Verbatim: Lactic Acid 3.2) (serious criteria hospitalization). The outcome of the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal were resolved.   It was unknown if the reporter considered the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal to be related to Shingrix.     It was unknown if the company considered the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient was reporter's husband. A day later of vaccination, the patient had flu-like symptoms and a fever (100 degrees).  Reporter called EMS and the patient was hospitalized for a few days. The patient was diagnosed with septicemia. The reporter did not consent to follow-up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-NOV-2015 00:38, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.7 and 2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
One week from 2nd and final dose broke out in hives. Intense itching and skin rash on both arms and entire trunk area. Also effected face and neck.
became very ill; couldn't move head because of the tremendous pain in the head; would start vomiting, even if there was nothing to vomit; This is a spontaneous report from a contactable consumer (patient). A 9-decade old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 86 years old) as dose number unknown, single for COVID-19 immunization. Medical history included pacemaker, Meniere's disease and implant in head, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient became very ill on an unspecified date in Mar2021, couldn't move head because of the tremendous pain in the head and would start vomiting, even if there was nothing to vomit on an unspecified date in 2021. The patient was hospitalized for becoming very ill on an unspecified date.  It was reported that the patient had the COVID shots in the latter part of February. On an unspecified date in March, one month to the day, she became very ill and was in the hospital. The next month, on the same day, she was in the hospital again very, very ill. The next month and 2 weeks later, she was in the hospital again; same thing, very very ill. She didn't think that she would be able to beat it if it happened again. Then it happened again and she was in the hospital for 5 days that time. She added that one minute she would be fine and the next minute she would be deathly ill. She would be woken up out of her sleep deathly ill and couldn't move her head because of the tremendous pain in her head. She would start vomiting, even if there was nothing to vomit. Her daughter would call 911 and they would come and get her and take her to the hospital. She never had the flu or colds her whole life. She gets other things that were weird. The patient also added that she has Meniere's disease. Her doctor told her that what she had happen with the shots was so different and it was not from Meniere's disease. She also has an implant in her head from her ear and her doctor said that had nothing to do with it as well. She also has a pacemaker, and the doctor says that has nothing to do with it either. The patient clarified that she has already reported her adverse events and hospitalizations after the Pfizer Covid vaccine. She was calling now to let Pfizer know that the doctors have said that her adverse events were not related to her Meniere's disease, her implant, or her pacemaker. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.