chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coma; Difficulty standing; Motion difficulties; This case was reported by a consumer via call center representative and described the occurrence of coma in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On 29th September 2018, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, 18 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced coma (serious criteria hospitalization and GSK medically significant), difficulty in standing (serious criteria hospitalization) and movements reduced (serious criteria hospitalization). On an unknown date, the outcome of the coma, difficulty in standing and movements reduced were recovered/resolved.   It was unknown if the reporter considered the coma, difficulty in standing and movements reduced to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported, but the patient was 81 years old at the time of reporting. About 18 hours after receiving vaccines, the patient went into coma and was hospitalized for a month. The patient also experienced difficulty standing and motion difficulties for 2 months.  The reporter did not consent to follow up. No further details were provided.
immed p/recvd vax c/o burning sensation & scalding type pain lt deltoid; hard red raised area 40cm indcater; redness down lt arm, joints in lt hand/fingers ached & arm painful; Throat constricted w/difficulty swallowing; lt side of body ach
This spontaneous report has been received from a pharmacist referring to a multiple patients of unknown age and gender. Information regarding patient's medical history, drug reaction, allergies, concurrent conditions and concomitant  therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23 , (strength, dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis. On an unknown date, the patients experienced unspecified pain, swelling and warmth at the injection site. At the time of reporting the outcome of unspecified pain, swelling and warmth at the injection site was unknown. The relatedness between the events and PNEUMOVAX23 was not reported.   Additional information has been requested.
DTaP given 4/8/08 in Lt thigh.  Afternoon/eve of 4/9/08 - L thigh red & swollen.  Swollen & red from diaper line to knee.  Warm, fever 102 degrees 4/10/08.  4/12/08 - swelling subsided.  Still on 4/14/08 looks bruised & greyish, still tender.  Used dry heat to area & Tylenol.
Small lump at the injection site; Redness at the injection site; Bruising at the injection site; A spontaneous report  was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site, bruising at the injection site and small lump at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced redness at the injection site (injection site erythema), bruising at the injection site (injection site bruise). On 15 Feb 2021, the patient experienced  small lump at the injection site (injection site mass).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
patient reported complaints of metallic taste, heaviness of chest,  and c/o neck feeling "tight" as though it needed to have pressure relieved.   VITALS: T97.5 HR 86 RR 16, BP 122/88  Patient was given snack and gatorade and all symptoms resolved within 10 mins.
I already had a little bit of swelling in my left hand from the first dose of the vaccine, but within about 8 hours my left hand swelled up and both hands became painful. It went into my wrist and I had trouble bending my fingers. I knew very quickly something was going on. I am a very healthy person and never have problems and I am able to function very well for my age. I knew pretty quickly that something wasn't right. I muddled through work the next week and only worked 28 hours and I haven't been able to maintain that schedule because of the pain. I bought arthritis cream because of the pain in the night. By the next Friday (05/21/2021) I tried to reach out to the doctor and got an appointment within a week and she ran blood tests. She did a rheumatoid test. Blood test came back as some type of autoimmune disease and she also tested for lupus and part of the autoimmune response problem was basically that this could be Lupus-SLE. She hooked me up with a specialist and I saw them on Tuesday and they ran blood tests and I don't have those results yet. It radiates into my shoulder sometimes that incapacitates me. I have trouble with everything even cutting a pancake and raw vegetables. I have debilitating pain and jolts of electric pain especially in right fingers. It's been a life changing event. I've had to be so dependent on people at work. I am exhausted by the time I do get ready for work. In the morning I can't even shower because my hands aren't flexible enough to roll my hand around the wash cloth. I took a pic of my hand the night after vaccine and people who saw my hand couldn't believe what my hand looked like. The one thing I've learned that does help is a little bit of hand exercises in the pool, movements up and down and back and forth, water resistant but that is very temporary. On May 1 I came home from a trip and May 2 in addition to my left hand being swollen, my ankles were swollen after a flight. I've traveled around the world as a flight attendant and never had this issue. My ankle swelling went down but not my hands. I also had joint pain.
Initial misuse report received from a healthcare professional on 1 JULY 2013. It was reported that ADACEL was given to an 18-month old patient as the 4th dose in the series. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
SEVERE PAIN IN LOWER LEFT BACK AND HIP AREA, PATIENT WENT TO PRIMARY CARE PHYSICIAN FOR TREATMENT
Swelling and readiness to the left deltoid area.   The client denied any pain or discomfort to the area.
This case was reported by a healthcare professional and described the occurrence of itching in a 47-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included DTAP (Sanofi), VARIVAX (Merck) and yellow fever vaccines (Sanofi) all given on 10 March 2010. On 10 March 2010 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm. On 17 March 2010, 7 days after vaccination with TWINRIX, the subject experienced itching and scab formation. The events resolved on 14 April 2010. The healthcare professional considered the events possibly related to vaccination with TWINRIX. On 14 April 2010 the subject received 2nd dose of TWINRIX at 1.0 ml again in the left arm. Later the same day after vaccination with TWINRIX, she experienced itching and scab formation. The events resolved on an unknown date. The healthcare professional considered the events probably related to vaccination with TWINRIX. The subject was referred to a physician for follow-up for the 3rd dose of TWINRIX.
pt recv vax & devel a raised confluent rash all over;pt devel swollen & tender feet & a fever of 102-103;4/8/98 pt devel new single spots;tx w/pred, APAP & Ibuprofen;
Extreme flare of neurological pain in my right arm and hand.  This is a level of pain I have never experienced before, which leads me to believe it may have been triggered by the flu vaccine.
ARM WAS VERY SORE TO TOUCH AND MOVEMENT FOR TWO DAYS.  FELT CHILLED AND TIRED ABOUT 4-6 HOURS AFTER SHOT.  WOKE UP THE NEXT MORNING AND CHILLS AND FATIGUE WERE GONE.  7 DAYS AFTER SHOT A RED OVAL SHOWED UP NEXT TO THE INJECTION SITE.  IT IS SLIGHTLY WARM TO THE TOUCH AND SLIGHTLY SWOLLEN.  IT DOES NOT ITCH OR HURT.  JUST IS RED AND A LITTLE WARM.
Child was developing hives on body.  Child also was wheezy sounding with breathing.  Child was taken to local hospital emergency room and given a nebulizer breathing treatment and injectable benedryl.
first dose on 18Jul2021 / not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 39-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 18th July 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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 age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix , which led to incomplete course of vaccination. The pharmacist states the first dose was given at another location, so the lot and expiration of dose 1 are not available. The reporter consent to follow up.
27Apr90 pt vax; vax was inadvertently reconstituted w/ Hib Titer instead of diluent provided.  No adverse reactions.
Sever fever near 103, sever chills, severe headache, pain and aches throughout body,  loss of strength , severely tired
Crippling migraine. Lasted from about 8 p.m 6/22 until 12 p.m 6/23. Ibuprofen was ineffective in helping.
reports sx of sore throat, nausea, and stomach ache started 8/22/2022- tested positive for covid 8/24/2022
Information has been received from a physician concerning a patient who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced fever and aches.  The patient's outcome was not reported.  Additional information has been requested.
BLOODSHOT IN EYE/EYES WERE RED; KNOT IN CENTER OF RIGHT ARCH OF FOOT; NECK HURTS/COULD NOT MOVE NECK; HEAD SWELLING AND TENDER; SLEEPY; HEADACHE; CHILLS; HEART ACHE; This spontaneous report received from a patient concerned a 64 year old African American, not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 between 09.30 and 09.40 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (Aspirin) for blood pressure. On 08-APR-2021, 20 minutes after vaccination, the patient started having symptoms. The patient's heart started aching and that lasted for 15-20 minutes and then went away. On 09-APR-2021, the patient had chills that had lasted for four hours. On 10-APR-2021, the patient could not move his neck left or right and back of his head felt like it was swelling and  tender; he also had a headache, and he was extremely sleepy. The patient's neck and head tenderness lasted three to four days. On 11-APR-2021, the patient eyes had blood shot and were red and reported that he might had a stroke or blood clot. On 17-APR-2021, he had a knot came up in the center of right arch on foot. On 19-APR-2021, at the time of this report, the patient's eyes were still red and had a slight headache; the patient's neck still hurts, he was sleepy, and the knot was still there on his right arch of his foot. The patient took acetylsalicylic acid (Aspirin) but he was already taking that for his blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart ache on 08-APR-2021, head swelling and tender on 14-APR-2021, and chills on 09-APR-2021, and had not recovered from neck hurts/could not move neck, bloodshot in eye/eyes were red, headache, sleepy, and knot in center of right arch of foot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 64-year-old African American (non-Hispanic/Latino) hypertensive male patient reported "heart aching" 20 minutes after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The event lasted for 15-20 minutes.  Other associated symptoms developed in the succeeding 3 days: chills that lasted for hours, could not move his neck and felt it was swelling and tender, headache, sleepiness, blood shot eyes.  Nine days after vaccination, the patient reported he had a knot in the center of arch right foot.  The patient took Aspirin.  No other details was reported.  The event is confounded by the underlying hypertension.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Vasovagal syncope, the patient had waited approx. 12 minutes after her injection at 8:30 am and started feeling dizzy. She slumped over and rolled onto the ground. She was assisted to a gurney from the floor. She was given snacks water and juice and was observed for approx. 45 minutes. V.S remained stable and the patient was sent home.
redness at injection site; swelling at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced redness and swelling at injection site.  The reporter wanted to know if this was an allergic reaction. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Cold, sweats, shaking, nausea, diarrhea, itching, swelling, weak leg.
THROAT HAS CLOSED; DIFFICULTY BREATHING; FULL BODY RASH BRIGHT RED AND PUFFY (LIKE A BAD CASE OF POISON IVY); FLU-LIKE SYMPTOMS; KNOT AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 42 year old female of unspecified ethnic origin and race. The patient's height, and weight were not reported.  The patient's concurrent conditions included: sulfa allergy, and penicillin allergy.  The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 19-AUG-2021, the patient experienced flu-like symptoms, headache and fever. On 20-AUG-2021, the patient experienced full body rash bright red and puffy (like a bad case of poison ivy).  On 22-AUG-2021, the patient experienced throat has closed and difficulty breathing On AUG-2021, the patient experienced knot at injection site and high blood pressure Laboratory data included: Blood pressure (NR: not provided) 190/120 mmHg. The patient visited hospital and visited emergency room (8 times). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body rash bright red and puffy (like a bad case of poison ivy), difficulty breathing, high blood pressure, knot at injection site, flu-like symptoms and throat has closed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849527-Covid-19 vaccine ad26.cov2.s- High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
10FEB93 pt felt sick, vomited devel rash, temp 100; 12FEB93 neck swollen, t102; 13FEB93 MD appt started on Amoxicillin ?ear infect;
Patient was anxious to receive vaccine. Reassured patient. Verified no allergies. Patient was fine 15 minutes after flu vaccine. 30 minutes later had lump in throat.
Couldn't eat nor drink anything; Nauseous for a period of 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours). On 17-Mar-2021, EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Breakthrough COVID + Traveling for work - Woke early morning 28Mar2022 ~ 1am feeling quite ill, cough, headache, joint/body pain, nasal and chest congestion Found a 24 hour pharmacy for a home COVID test. Went back to hotel test returned positive.  Tested again 31Mar2022 still postitive Tested again 03Apr2022
Fever of 100.5; Chills; Headache; 24-48 hour symptoms: body aches; Sore/stiffness at injection site; Sore/stiffness at injection site.; 14 day symptoms: blue and yellow bruising at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 09:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included vitamin d nos (VITAMIN D), cetirizine hydrochloride (ZYRTEC) and ascorbic acid (VITAMIN C), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 10Sep2021, the patient experienced 24 hours symptoms: fever of 100.5 (unspecified units), chills, headache. 24-48 hours symptoms: body aches, sore/stiffness at injection site and 14 days symptoms: blue and yellow bruising at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events 24 hours symptoms: fever of 100.5 (unspecified units), chills, headache was resolved on 11Sep2021, 24-48 hours symptoms: body aches, sore/stiffness at injection site was resolved on an unknown date in Sep2021 and 14 days symptoms: blue and yellow bruising at injection site was resolved on 24Sep2021.
A 3-year-old child had received their two and four month Hib immunizations (manufacturer, lot number and dates of administration not reported) and subsequently developed Hib bacteremia and meningitis in late February 2009. The child was reported to have been under-vaccinated and had not completed the Hib vaccine series with the six month and 12-15 month vaccine doses. At the time of the report, the child was hospitalized in intensive care and recovering. No further information was provided. Documents held by sender: None.
Onset of joint pain/inflamation in left ankle with no injury occurred within days of vaccination; general increase in join pain in lower extremities; Unclear that there is linkage to the vaccination, but there appear to be reports of correlation between COVID vaccines and joint pain/arthritis, which made me believe that their may be some linkage
nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
While in post vaccination observation area, asked for water and then slid to the floor. vital signs stable, given a snack and felt better. He did receive the 2nd vaccine dose on 05/19/2021 without incident