chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe hives; itchy hives; chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives), PRURITUS (itchy hives) and URTICARIA CHRONIC (chronic hives) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA CHRONIC (chronic hives). On 17-Dec-2021, the patient experienced URTICARIA (severe hives) and PRURITUS (itchy hives). At the time of the report, URTICARIA (severe hives), PRURITUS (itchy hives) and URTICARIA CHRONIC (chronic hives) had not resolved.            No Concomitant Medications were provided. On 25 Dec 2021 Patient went to an urgent care where they gave her a shot on her butt and was given 2 oral allergy medications to take.   This case was linked to MOD-2022-441495 (Patient Link).
HANGOVER EFFECT/HANGOVER; FEVERISH/FEEL LIKE HAVE FEVER; HEADACHE/HEAD HURTS; PRESSURE FELT WHEN INJECTING; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced pressure felt when injecting. On 08-APR-2021, the subject experienced hangover effect/hangover. On 08-APR-2021, the subject experienced feverish/feel like have fever. On 08-APR-2021, the subject experienced headache/head hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pressure felt when injecting, and had not recovered from hangover effect/hangover, feverish/feel like have fever, and headache/head hurts. This report was non-serious.
LPN was administering Tb skin test and Flu vaccine - accidently administered influenza sub-q right forearm.  Right forearm slightly red
Adult Tdap given Lot # B2435 exp 4/3/18. GlaxoSmithKline - Manufacturer. Site - LD.
Patient presented to the pharmacy on 7/6/23 with redness and burning just below the deltoid on her right arm. She reported that it started the day after her vaccine and started on the deltoid area and spread down her arm. She reported taking APAP to help with the burning sensation.
Woke up at 2 a.m. felt tightness in throat went bathroom right side of face was drooping by mouth and speech was very slurred went to hospital an had various tests done
Pt. was given a MMRV when she was only due for a MMR. This means she got a 3rd does for Varicella.  She states she has not reacting after given the wrong vaccination. This event happened on 06/02/2023 in the afternoon.
ABOUT 15 MINUTES AFTER VACCINATION, TYHE PATIENT  COMPLAINED OF ARM NUMBNESS, TINGLING IN MOUTH/TONGUE AND METALLIC TASTE.  THE PATIENY WAS ADMINSTERED 50MG OF BENADRYL AND MONITORED FOR AN ADDITIONAL 30 MINUTES. THE PATIENT SAID THE TINGLING IN TONGUE IMMEDIATELY RESOLVED AFTER BENADRYL AND JUST HAD MINOR ARM SORENESS.
received Arexvy and the flu shot in the left arm on same day; injection site arm red; headache; itchy left arm; Injection site arm swollen; Hot arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy (left arm) and Flu vaccine (left arm). In OCT-2023, several hours after receiving Arexvy and Flu vaccine, the patient experienced erythema of extremities (Verbatim: injection site arm red), headache (Verbatim: headache), itchy upper limbs (Verbatim: itchy left arm), swelling arm (Verbatim: Injection site arm swollen) and extremities hot feeling of (Verbatim: Hot arm). On 16-OCT-2023, the patient experienced wrong technique in drug usage process (Verbatim: received Arexvy and the flu shot in the left arm on same day). The outcome of the erythema of extremities, swelling arm and extremities hot feeling of were resolving and the outcome of the headache was resolved and the outcome of the itchy upper limbs was not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she received Arexvy and the flu shot (for ages over 65) in the left arm, which led to wrong technique in drug usage process. She stated hours later, injection site arm got red, hot and swollen.  She stated that it was getting a little better but it was itchy now.  The concomitant medication included as Benadryl and Allergy Medicine. She also stated that getting a headache hours after the vaccines but it had since resolved.  The reporter did not consent to follow-up.
pt recvd vax & in 10mins became clammy, cool skin & blurred vision-BP 132/72, P92, given Epi BP 128/82, P82
Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/2021 (like I had foot blister or stubbed a toe). Then, I had petechiae with discoloration on 1/16/2021 and 1/17/2021.  With my preexisting Raynaud, I believe the COVID toes again (pictures attached) are a COVID vaccine immunogenic response rather than COVID infection itself given my serial negative COVID PCR, absence of other symptoms, and only home/work social bubbles for > 7 days. I have reported to Pfizer for vaccine adverse events.
Information has been received from a physician concerning a 46 year old male patient who on 17-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot number 662667/1435X). Concomitant therapy included influenza virus vaccine (manufacturer unknown), NEXIUM, alendronate sodium (MSD), WELLBUTRIN, allopurinol, levothyroxine Na, carvedilol, enalapril maleate (manufacturer unknown), warfarin, LORTAB, vitamins (unspecified), ibuprofen and colchicine. The patient was also on therapy with CELEXA 20 mg. On 18-SEP-2009, the patient experienced an adverse reaction. The event was a red ball or knot at the injection site, warm to touch with red streaks going down the arm. No medication was given. There was no ER visit, hospitalization or significant disability. The patient did not die or had life threatening events. At the time of the report the patient's outcome was unknown. Follow up information received on 25-SEP-2009 from licensed practical nurse indicated that the patient was a male, with a medical history of gout, arthritis, depression and allergies to PERCOCET and nitroglycerine, who was vaccinated with dose of PNEUMOVAX 23 (lot number 662667/1435X), intramuscularly into the right deltoid. Concomitant vaccination given on 17-SEP-2009 included a dose of FLUZONE (lot # U3195AA), intramuscularly into left deltoid. Concomitant therapy included prednisone. On 13-AUG-2009 the patient started therapy with CELEXA. On 04 November (year unknown) the patient started therapy with alendronate sodium (MSD). On 30 November (year unknown) the patient started therapy with NEXIUM and allopurinol. The patient was also taken warfarin 5 mg until 13-AUG-2009. On 18-SEP-2009 the patient experienced red arm, with a ball size knot, warmth to touch and painful. The patient goals were International Normalized Ration 2.4-2.6 and blood pressure 100/< dizzy. The patient recovered on an unspecified date. No further information is available. This is an amended report. The concomitant medications were added.
1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.
Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now.  Flu like symptoms, diarrhea,dizziness, very weak.  Short of breath, low pulse o2.
PATIENT MOTHER CALLED THE OFFICE AN HOUR AFTER VACCINE AND SAID HE WAS HAVING A SIEZURE, CALLED EMS-PATIENT IS 18 AND REFUSED TREATMENT . MOM WAS URGED BY OUR OFFICE TO TAKE HIM TO ER IMMEDIATELY
Information was received from a pharmacist concerning a 67 year old male patient. On 28-OCT-2013, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included PROAIR, Atorvastatin, PLAVIX, terazosin hydrochloride and hydrochlorothiazide, losartan potassium. On 29-OCT-2013, the patient experienced injection redness and heat. On 30-OCT-2013 the patient had more pronounced injection site symptoms including redness, heat and a large knot at the site of injection. The patient was treated with an unspecified antihistamine. At the time of this report the patient had not recovered. Lot number J008629 is not valid. Additional information has been requested.
pt had an episode of a fib on 11/19/23. Was treated with diltiazem on 11/19/23. Discontinued diltiazem on 11/22/23.
Got both shots then got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got both shots then got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient got both shingles shots, then got shingles afterwards.  The reporter stated that no thank you to both. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The reporter was the patient's wife.  The patient had his first Shingrix dose about 2 weeks ago. The patient developed diarrhea soon after and it resolved after two days. Nothing else was reported.  The reporter declined to provide DOB (Date of birth). The reporter did not consent to follow up. Additional Supportive Information:  This case has been linked with case US2022137993 reported by same reporter.; Sender's Comments:  US-GSK-US2022137993:Same reporter
11 month old patient received a dose of menquadfi with no adverse event reported; Initial information received on 09-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 months old male patient who received a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB) for Immunisation.  On 30-Nov-2022, the patient received 0.5 ml (milliliter) (1x) (once) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot U7576AC, expiry date: 28-Feb-2025) via intramuscular route in right thigh for immunization.  On 30-Nov-2022 the reporter reported that 11 month old patient received a dose of menquadfi with no adverse event reported (product administered to patient of inappropriate age) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After getting flu shot (unknown), experienced severe body aches, chills, headache, dry mouth, extreme fatigue, skin sensitivity.
Child in not 5 years old and was given the dose for a 5 year old. He does weigh 64 pounds. No adverse event occurred. Patient did well.
Saturday (10/4) - arm swollen (L), couldn't move it. Seen at urgent care, given MOTRIN. Ice. Sunday (10/5) - high fever, added TYLENOL. Monday (10/6) - fever, swollen arm, pain. Prednisone given at MD visit.
Patient described large area of pain and swelling at and near the site of injection.  Resolved after nearly a week.
Child fainted and may have had a seizure, child transported by EMS to hospital for further evaluation.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine were 04-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine were 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: pfizer (2nd Dose) on 21-Jan-2021, pfizer (First Booster Lot number- 32030BD) on 25-Oct-2021 and pfizer (1st Dose) on 31-Dec-2022. Past adverse reactions to the above products included No adverse reaction with pfizer, pfizer and pfizer.    On 04-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine were 04-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine were 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine were 04-Aug-2022).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
This spontaneous report as received from a registered nurse refers to a 57 year old patient of unknown gender, who was also a nurse. Concurrent or medical conditions were not reported. The nurse reported that on 18-JUN-2015, the adult patient (not a child or adolescent) was vaccinated with the first dose of (Oka-Merck) PROQUAD subcutaneous (dose, strength and lot number were not reported). The patient was also administered a dose of (Oka-Merck) PROQUAD. No adverse effects reported. Additional information has been requested.
I started running a slight fever the following day, I was feeling like i was having heart issues. A crushing feeling in my chest. It went on for about a month. It got worse with exertion. Ventricle Hypertrophy
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-APR-2015, the patients were vaccinated with improperly stored COMVAX lot # J002621, expiration date- 29-NOV-2015, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Heart Palpitations; Injection site pain/tenderness; Fatigue; headache; muscle pain; Joint pain; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Feb-2021, PALPITATIONS (Heart Palpitations) had resolved. On 13-Feb-2021, INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 degree Celsius (High) fever is recovered after three days..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
pt recvd vax & devel a severe local rxn of redness @ inj site;pt also exp fevers and body aches;this is one of nine pts who exp above rxn;
I just felt like I had a mini panic attack with sweating, nervousness, and got lightheaded.
Very very weak; Headache; Fever; Throwing up; Earache; Diarrhea; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, earache, fever, throwing up, diarrhea, very very weak.  The patient's medical history was not provided. Concomitant medications reported were Blood Pressure medicine.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced headache, earache, fever, throwing up, diarrhea. On 1 Feb 2021, the patient experienced the events very very weak.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.   On 30 Jan 2021 the outcome of headache, earache, fever, throwing up and diarrhea was resolved.  The outcome of very very weak was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever up to 101.8 Sever body aches from hip to topic head Sore arm
Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911.
J96.00 ACUTE RESPIRATORY FAILURE 8/7/2022 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 8/7/2022 ATRIAL FIBRILLATION, PERMANENT J96.00 ACUTE RESPIRATORY FAILURE 8/7/2022 ANEMIA DUE TO BLOOD LOSS
Muscle soreness at injection site about 24 hours after injection.  After about 48 hours, itchy hives forming  on left arm,. Hives on arms mostly resolved within 5 days, but presently, about ~3 weeks post injection, observing uticaria/hives throughout the body; especially on torso.
Information has been received from a physician concerning a 16 year old male patient who on 01-AUG-1994 at age 1 day was vaccinated with the first dose of RECOMBIVAX HB (lot# not reported) thimerosal containing. On 03-OCT-1994, the patient received the second dose of RECOMBIVAX HB (lot# not reported) (lot# 611290/0048A) and on 06-FEB-1995 was vaccinated with the third dose of RECOMBIVAX HB (lot# 613382/1065A) thimerosal containing. Concomitant therapy included ACEL-IMUNE (lot # 4H51058 (D1), 7390AA (D2), HIBTITER (lot # 312-935 (D1)), ORIMUNE (lot # 314-9360700H (D1) and 314-070014 (D2), and MMR II (lot # 630119/1983H (D2). The patient had initial hepatitis B series and was no longer immune per blood test titers. On 23-AUG-2010, the patient had a hepatitis B surface antibody test performed showing <5. This is one of several reports from the same source. No further information is available.