chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stiffness in ankles; after each of covid-19 vaccine had reaction to vaccine; Diarrhea; tired; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiffness in ankles), IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced JOINT STIFFNESS (stiffness in ankles), IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever). At the time of the report, JOINT STIFFNESS (stiffness in ankles) had not resolved and IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
First dose of vaccine administered after excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medications were not reported.   It was reported that the vaccine temperature was never checked throughout the day. The reporter stated that the vaccines were above 46 degrees F (Fahrenheit) after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times.   No treatment information was provided by the reporter.     This case was linked to MOD-2021-250531 (Patient Link).
Pt reports a rash starting from the injection site (deltoid) to the elbow with severe itching at the palm of the hand. Pt was given authorization by her physician to get a flu shot. Pt. has an EPIPEN d/t previous rx to said products that caused swelling of tongue/throat. Rx subsiding with BENADRYL.
This spontaneous report as received from a Registered Nurse concerning a patient of unknown age and gender who on 17-JAN-2013 was vaccinated with dose 3 of GARDASIL (Lot number H016960, Exp 02-DEC-2013) that was exposed to minus 10 degrees C for 4 hours. No adverse symptoms reported. Additional information has been requested.
difficulty of breathing and tiredness are among the commonly reported adverse events after more than 2 weeks of getting the 2nd dose; more frequently now.; difficulty of breathing and tiredness are among the commonly reported adverse events after more than 2 weeks of getting the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in right arm on 13May2021 at 11:00 (at the age of 48 years old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing asthma (diagnosed with asthma when she was 13 years old) and ongoing chronic obstructive pulmonary disease (diagnosed with COPD 4-5 years ago). Family Medical History Relevant to AE(s): ongoing Heart Disease. Relevant Tests: None. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient took ProAir (Twice daily for 5 years or longer) and Albuterol (puffs twice daily for 5 years or longer) for asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No adverse events following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in Arm Right on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient got her second dose of the Pfizer Covid-19 Vaccine on 13May2021 and ever since she felt extremely tired and her difficulty of breathing worsened. The patient was supposed to go to work but was so tired that she went home and just went to sleep. Patient felt tired all the time and while she was driving, stated that COVID-19 vaccine was bothering her breathing. The patient reported that she had asthma and COPD and was using her medication more frequently now. The patient reported that when she woke up on 14May2021, she could not breathe. The patient reported that she sat down for a minute to rest because it was hard to get air. She reported that she had already used her inhaler twice today, 01Jun2021. The patient reported that she was supposed to use the ProAir inhaler (lot number: DAE90A) twice daily but had been using it 5, 6, 7, or 8 times daily since receiving the second dose of the COVID-19 vaccine. Instead of using 2 puffs, she took 4-5 puffs because the prescribed 2 puffs twice daily was not working. The patient reported that she would get a few minutes of relief after using the ProAir inhaler. Adverse event did not require a visit to emergency room/ Physician Office. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Arm swelled from vaccinations site approx 2 inches below shoulder bone to elbow the following day (5/30/18). Symptoms include swollen, itchy, warm to touch. Treated with ice. The swelling has decreased since vaccination.
Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching all over the body and muscle aches. I feel like a lump in my throat and I feel very tired.
Pt recvd series of 3 Engerix-B vax on 6MAR91, 10APR91 & 11SEP91; following the series NOV91 did not respond plan is to revax;
syncope & diaphoresis 5min p/vax remained alert & oriented-rested & lt p/20';
CRAMPING. THEN ABOUT 9:00 PM, SEVERE CRAMPS. AT 10:00PM-DIARRHEA.  CRAMPS IN WAVES, THEN DIARRHEA AGAIN AT 11:00. CRAMPS IN WAVES, THEN DIARRHEA AGAIN AT 12:00AM.  MORE CRAMPING, THEN THEY EASED AND I FINALLY WENT TO SLEEP.  AM PERFECTLY FINE THIS MORNING.  MY HUSBAND AND I ATE THE EXACT SAME THINGS THIS WEEKEND AND HE WAS FINE SO NOT FOOD RELATED.  I WAS FINE BEFORE 8:00PM.
WARM TO TOUCH; SORENESS ON THE LEFT ARM (INJECTION SITE)/SORE; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 125 kilograms, and height was 170 centimeters. The patient's concurrent conditions included alcoholic, non-smoker, and herpes, and other pre-existing medical conditions included patient had no known allergies, no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced warm to touch. On 09-APR-2021, the subject experienced soreness on the left arm (injection site).  Laboratory data included: Pain scale (NR: not provided) 4/10 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness on the left arm (injection site), and the outcome of warm to touch was not reported. This report was non-serious.
Leg swollen, red, painful, hot to touch MD feels allergic reaction, treated with ice to area, elevation, prednisone PO, Benadryl, reaction resolved completely within 3 days.
F1st dose of Havrix on 12Oct2022 and an early 2nd dose on 12Nov2022.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17th June 2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX), HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 12th November 2022, the patient received the 2nd dose of Havrix. On 12th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.    Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment: The patient also received the 1st and 2nd dose of Engerix on the same dates of Havrix on 12th October 2022 and 12th November 2022. The reporter reported that patient received the 1st dose of Havrix and an early 2nd dose. The reporter consent to follow-up. Additional Supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccinations schedule. ; Sender's Comments:  US-GSK-US2022180225:Same reporter
01-17-13 1230p Client's mother telephoned to report: Client c/o arm pain as soon as he got home from getting flu shot yesterday. She is out of town and rec'd a phone call from a school nurse advising client has a temp of 101F and c/o severe arm pain going into axilla referred client's mother to their pediatrician. Mother awaiting dr return call.
12 hours after receiving the vaccine on saturday afternoon experienced severe headache sunday morning. was able to work through it. subsequently developed vertigo on monday night and missed work on tuesday. very unusual for this employee. now on tuesday evening symptoms are wearing off. did not seek medical attention.
At 10PM the night I received my vaccine, I began running a fever. I took a Tylenol. The next day, I spent the whole day sleeping and had a fever all day that I continued to treat with Tylenol. After that, my feet, legs, arms, and stomach began to itch. Saturday morning, I felt a little bit better and tried to get out of bed and move around which helped me to feel a bit better but by that evening, I was feeling badly again and had to lay down because I was feeling woozy and week. Sunday, 07/10/2022,  I was unable to eat due to nausea. Monday, I was still tired to the point that I could only work half  a day and I went to bed early. Yesterday and today, I have been feeling tired and have had a headache. I also noticed some numbness and a rash in my mouth on 07/10. I took a Benadryl and it has cleared up now.  I have an appointment with the doctor tomorrow where I can discuss these issues.
20JUL96 lethargic;severe h/a, pain in ankles;t99-100;APAP given 24JUL96 by MD who treats pt for allergies on 25JUL96 for knee pain;put to bed;mom told need to contact all MD caring for past & present conditions;
After 2 hours or so of taking the first dose of the Pfizer vaccine, I started feeling numbness and tingling all over the body specially in the hands and face. After 3 days it got worse and my hands started shaking a bit but could barely feel if I was holding something or not. Swallowing was painful and walking felt strange. Went to the er and the doctor told me it was inflammation and recommended to still take the second dose. After a week it got better. But when I took the second dose the effects came back again. Not as strong as when they started but it?s been more than a month since the second dose and I still have the symptoms.
Apneic event with stiffness and cyanosis followed by floppy and decreased arousability slowly resolving suspicious for 30-90 sec seizure about 4 hour after first set of immunizations
(R) leg inj spot 1 cm (R) lateral thigh, erythema, fussy, spitting up 1/15/14, lump (R) leg, (+) fever.
On/off fuzzy or wavy lines in the eye; eye disorder NOS; Loss vision; Dizziness; bed all the day and couldnt move at least for 30 hrs; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Loss vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 17-Mar-2021, the patient experienced BLINDNESS (Loss vision) (seriousness criterion medically significant). On 11-May-2021, the patient experienced EYE DISORDER (eye disorder NOS). On an unknown date, the patient experienced EYE DISORDER (On/off fuzzy or wavy lines in the eye). On 26-Feb-2021, MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs) had resolved. On 17-Mar-2021, BLINDNESS (Loss vision) had resolved. On 11-May-2021, EYE DISORDER (eye disorder NOS) had resolved. At the time of the report, EYE DISORDER (On/off fuzzy or wavy lines in the eye) and DIZZINESS (Dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Ophthalmological examination: couldn't find any eye damage (normal) Couldn't find any eye damage. On 02-Apr-2021, Magnetic resonance imaging head: shows mild atrophy (abnormal) shows mild atrophy and everything seem okay.         Concomitant product was not reported. Laboratory investigations included brain MRI and the result showed mild atrophy. Treatment details was not reported.  Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Redness, hot to touch, itching that traveled down the arm after 1 week of the injection.  First red spot occurred at the injection site the day after the injection; spot was hot to touch, had a lump, and itching and lasted over a week.  2nd splotch showed up after a week and is hot to the touch, tender and itches.   Have not sought additional medical care as of this report 5/5/2021.
became pale; This spontaneous report was received from a field employee on behalf of an office manager concerning a female patient of unknown age.    The concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, frequency, lot# and the expiration date were not reported) for immunisation.         Subsequently after received the vaccine, the patient became pale (pallor), sought medical attention and had to go to the emergency room. She would be schedule to follow up with a cardiologist.    The outcome of pallor was not provided. The relatedness between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not reported.
24OCT pt recv vax & 2NOV96 redness, warmth, induration;pruritus & 4x3cm erythema @ inj site;also stiff neck, h/a, swollen arm (inj arm) & several lesions on abd which cultured negative;(no temp);
This spontaneous report as received from a physician refers to a 16 years old female patient. The patient was vaccinated intramuscularly with a 0.5 ml dose lot # (671463/1359AA) of GARDASIL on 08-DEC-2011. No other co-suspects were reported. There were no concomitant medications. The physician reported that the first dose on 08-DEC-2011 the patient had minor muscle aches, pains, tingling and general body weakness and that these were more prominent after the 2nd dose (date unknown). The patient sought unspecified medical attention. Therapy with GARDASIL was discontinued. The outcome of tingling, general body weakness, pains and minor muscle aches was reported as not recovered. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that date of refrigeration was 5/7/2021.
pt exp soreness of the injected arm p/receiving Typhoid vax; the reaction lasted 3-4 days;
administration of a pediatric dose to an adult patient; administration of a pediatric dose to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 31-year-old female patient who received HBV (Engerix B pediatric) (batch number 53yl7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. The action taken with Engerix B Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that pediatric dose was administered to adult patient, which led to underdose and adult use of a child product. No other details were reported. The reporter consented to follow up through email address.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Patient reported lifting heavy furniture on Sunday.  The following morning  a headache and in by evening the injection site had a red rash,  felt warm to the touch and slightly swollen
Headache, Fever, Nausea, Vomiting, Chills, Body Aches, Diarrhea
The patient experiences swelling, redness and itchiness in the site of injection, 24 hours after a TD vaccine was administered. Follow up on 06/18/2004:  Patient's doctor was contacted and stated that the patient recovered.
pt recv vax & w/in 5mins of inj,pt devel dizziness,weakness,sweats,& fatigue;this is one of four patients who exp above rxn @ this site;
Developed large amount of soft tissue swelling with surrounding erythema within minutes of injection. Central portion of swelling looked bruised. Treatment was Benadryl po, ice pack and observation.
Sensation of electrical shock going down my right arm.  This persisted for approximately 6 months and then self resolved
About 8 hrs after vaccination pt experienced "sharp" shoulder pain, swelling on arm, couldn't sleep, tyl 2x500 no relief, Ibu 800mg some relief, warm compress. I spoke with pt on 10/13-> "feeling better", swelling, decreased taking Ibu 400mg and can move arm. Still some pain and small rash under arm.
On 9/09/2022 had fever of 102.4, on 9/10/2022 started vomiting; on 9/11/2022 went to Urgent Care,  had fever of 101.9 and vomited once; 9/12/2022 had a rash all over body and face.
During vaccine administration the vaccine leaked due to faulty syringe, uncertain how much dose the patient received.  Contacted lead clinical pharmacist, district market manager, patients MD, patients son (medical poa) regarding the event.  On the day of the event, MD asked for our office to call on Monday following the event to discuss with one of her vaccine RNs, relayed that information to the patient and her son. Covering pharmacist/clinical lead spoke with MD and patients son and they decided to follow recommendations outlined in ACIP for leaked vaccine (when unable to quantify how much dose was administered) and administered the dose again.
ACHINESS; SORE THROAT; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced achiness, fever, and sore throat. The action taken with covid-19 vaccine was not applicable. The outcome of the achiness, fever and sore throat was not reported. This report was non-serious.
Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved and currently on second round of anti-virals; delaying second vaccine until shingles resolve
about 24 hours after the flu shot I have been experiencing nausea, stomach cramping, diarrhea (these side effects usually occur with other things that I am allergic to or a migraine 24 hours later). At this time still experiencing symptoms.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that the patient was administered expired ZOSTAVAX. No side effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.