chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, ATORVASTATIN from 11-May-2021 to an unknown date for Hyperlipidemia, GABAPENTIN from 30-Dec-2020 to an unknown date for Leg pain, LEVOTHYROXINE from 06-Mar-2020 to an unknown date for Thyroid disorder, BIOTIN, VITAMIN C [ASCORBIC ACID], BROMELAINS (BROMELIN [BROMELAINS]), FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VIT D3), MULTIVITAMINS [VITAMINS NOS], SENNOSIDE A+B (SENADE [SENNOSIDE A+B]) and MELATONIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk). At the time of the report, MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   This case was linked to MOD-2021-131229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient details (height, weight and race) and AE's updated. Concomitant medications added.
Severe ache/pain in arm from shoulder to wrist. Severity is mild through severe throughout the day and night. After 4 weeks it has not dissipated.
A spontaneous report was received from a registered nurse regarding an unspecified number of patients who received improperly stored GARDASIL, VAQTA, RECOMBIVAX HB and ROTATEQ between 26-NOV-2014 and 01-DEC-2014. No adverse symptoms were reported. The outcome was unknown. Additional information has been requested.
Exhaustion, joint aches, pain at vaccination site, lower back pain, shakes hands and legs, very fuzzy head, some shortness of breath, dizziness
Pt developed hive fever and eyes rolled back per mother. pt taken to ER who diagnosed pneumonia. Pt was previously well. Normal exam when vaccines were given.
CUSTOMER COMPLAINED OF BURNING , TINGLING OF ANKLES TO TOES AND GENERAL MALAISE . THIS PROGRESSED OVER COURSE OF TWO DAYS TO SWELLING AND LOSS OF ABILITY TO MOVE LEGS . PER PRIMARY CARE PATIENT REPORTED TO ER DEPT ON AFTERNOON OF 12/26/19 ;
Information has been received from a registered nurse concerning a 15 year old female patient who in December 2006 and March 2007, was vaccinated with a first a second dose of Gardasil, respectively.  On 07-DEC-2007, the patient was vaccinated IM with a third 0.5ml dose of Gardasil (Lot# 659435/1265U).  There was no concomitant medication.  On approximately 07-DEC-2007 about a month ago, the patient experienced intermittent abdominal pain in the right lower quadrant.  There was no report of radiation of pain, nausea, vomiting or diarrhea.  Unspecified medical attention was sought.  Laboratory diagnostic studies included liver function tests, complete metabolic panel, sedimentation rate and amylase.  All results were reported to be within normal ranges.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Following dose three, The pain in the right shoulder with limitations to movement (pain in the deltoid muscle along the nerve plexus remains persistent and at times worsening despite heat therapy, ice and exercises to eleviate.  This is consistent with Parsonage-Turner Syndrome--It has now been greater than 4 months  Additionally following dose 2, I did have noted an elevation in alkaline phosphatase and newly noted steatosis of the liver.   This was noted when I had a Cardiac CTA to evaluate the heart due to an episode of slow VT following the second dose as well.  The heart CTA was normal with no CAD and a zero calcium score; however this defect was noted on the liver which I ignored when I went for the third dose
Mother stated child awoke with swollen lips "looked like duck bill", scattered rash, with a specific blister area on right arm, upper deltoid area.  No fever or other complaints.  Went to ER.
Dizzy most of the day, worsens in the afternoon/night, foggy thinking, and lightheaded
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-APR-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, lot # and route of administration not reported). There was reported that vaccine was improperly stored. No adverse events were reported. Additional information has been requested.
pain at injection site, shortness of breath (off and on for 3 hours from 6PM-9PM on Saturday April 17)-felt like I was winded like after climbing up lots of stairs. Heartbeat a little more prominent/faster than usual.
6" wheal that itched badly but area OK next day;pt recv vax 2NOV98;
COVID vaccine administered 2 days after expiration date. Upon notification of vaccine administration error mother claims on and off cough for 1.5 months and sores on mouth for 2 months.  Parent denies appointment to check cough and sore on mouth. Per Pfizer the vaccine was stable and dose does not need to be repeated.
Patient is a 16 yo who was given a Moderna Booster (0.25 ml dose) in the left deltoid IM on 12/16/2021. Patient is not pregnant.
Fever T max 102, chills, nausea, vomiting, starting the night of vaccination 5/16/11. Patient was out of work 5/17/11 to 5/20/11.
Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 022j21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown.            No concomitant medication information was reported. The patient experienced the same reaction to the vaccine as the patient's wife did.   This case was linked to MOD-2022-494916, MOD-2022-494953 (Patient Link).
Been severely ill have cold swea, swollen lymph nodes,leg pain that feels like blood clots or swollen vessels dizziness temple swelling admominal pain went to several doctors and they say nothing wrong but I feel horrible like I was going to die heart beating fast cold feet and hands
History of varicella within 1 year of age per mom. Varivax given by HD on 8/3/99 and MD confirmed case of varicella on 4/28/01.
Immunization given at noon on 9/20; at 4:30 PM fever developed and pt had seizure at 5:30 PM. Taken to ER by medics. Released 4 hours later.
Presented to the ED with weakness, shortness of breath, hypoxic Was given decadron, remdesivir, albuterol, combivent, vitamin D3, zinc, melatonin, then BiPAP Patient was put on the ventilator Suspected to have bacteremia so she was started on vancomycin and cefepime Developed shock and was started on levophed and vasopressin.  Patient later died
Huge red, swollen, itchy site. Warm to touch. Injection not given in deltoid muscle. Injection was actually given below the deltoid muscle.
Sore under left arm, whelped up, headache paralysis in left hand for 2 weeks so that person who administered vaccine hit the brachial nerve possibly.
Vacicine had expired on 11/5 and was given past expiration on 11/8/21
Low Grade Fever (100.4), Burning Eyes, Headache, Body Aches, Lack of Energy
High Fever and chills for two days, shaking, aches and pains all over, chest pain, soar throat, headache.
A non-serious report of two doses of FluMist given on same day has been received from a nurse concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FluMist.  No medical history no concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006238 and MEDI-0006240 which were all received from the same reporter.
Left arm mild soreness and mild swelling at injection site; Left arm mild soreness and mild swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left, administration date 03Mar2021 (Lot number: EL3247) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reflux" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SPRING VALLEY VIT D3; SUPER B COMPLEX [VITAMIN B COMPLEX]; SPRING VALLEY CALCIUM 600MG PLUS VIT D3; HEALTH VIT C 500 MG WITH ROSE HIPS; EQUATE COMPLETE MULTIVITAMIN WOMEN 50+. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 03Mar2021 14:00, outcome "recovered" (Mar2021) and all described as "Left arm mild soreness and mild swelling at injection site". Therapeutic measures were not taken as a result of pain in extremity, vaccination site swelling. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19 since vaccination. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are needed. No further information is expected.
inject site was very red & swollen; fever began about 4-6 hrs p/recvd vax & about 7 hrs later fever was 104 ax; used APAP in 1 1/ doses; fever lasted another 1 1/2 days; cold compresses used on arm;
a few sec p/ vax, had shooting pain in lt upper extremities & 2 wk later, joint pain;was later dx as having chronic fatigue synd;
Follow-up information was received that provided additional event details, outcome, illness at time of vaccination and laboratory test. This case was considered medically important. Information regarding PREVNAR was received from a pediatrician regarding an 18-month-old male patient who received a dose on 18-Jun-2007 and experienced febrile seizure. The patient's concurrent illness includes rhinorrhoea (mild). The patient's twin sister experienced fever of 103 to 104 degrees Fahrenheit with PREVNAR on the same day (case HQWYE727221JUN07). Product was administered on 18-Jun-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 18-Jun-2007, the patient received a dose of PREVNAR. Six hours after administration, the child experienced febrile seizure with a body temperature of 105 degrees Fahrenheit. The patient was taken to the Emergency room. The patient continued to have two to three subsequent febrile seizures. On an unspecified date, the patient recovered from the event. Body temperature (results: 105 deg. F.) was done on 18-Jan-2007. Electroencephalogram (results: negative focus seizure activity) was done in 2007. No additional information was available at the time of this report.
Swollen lymph node below left collarbone. The swollen lymph node is approximately 4 inches from injection site.
Inflamed  Injection Site; Red Injection Site 7" below the shoulder bone; Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed  Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed  Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle). In September 2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected 7" below the shoulder bone/ vaccine was not given in the deltoid muscle) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed  Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site 7" below the shoulder bone) outcome was unknown.        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 medication was reported. No treatment information was provided. The patient was a nurse and she was sure that the vaccine was not given in the deltoid muscle.
pt recv vax 11JUN97 & was seen for well child exam on 10JUL98 & had just had varicella;mom reports mult lesions covering entire body;had resolved lesions on exam;
all the flu-like symptoms; body aches; sore; fever; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PAIN (body aches), PAIN (sore), PYREXIA (fever) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PAIN (body aches), PAIN (sore), PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PAIN (body aches), PAIN (sore), PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  Patient took second vaccine around Jan 28th 2021 and he doesn't have information for exact date Action taken with the mRNA-1273 vaccine in response to the events was not applicable.
Swollen lymph nodes in the breast; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in the breast) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in the breast). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in the breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
I had my first Moderna shot on April 18. Several hours after the shot, I had pain and swelling at the injection site and joint pain and I developed a fever that evening.  On May 2, I had joint pain and noticed a yellow, bruise-like spot at the injection site and a large red, painful, swollen area on my arm, just below the injection spot--these symptoms have continued through today (now the red area is bigger and itches).
one patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported.  On 12-MAR-2020, the patient was vaccinated with improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660958, expiration date: 23-FEB-2021, orally for prophylaxis. Administered dose of vaccine was stored in the lowest temperature below 36 Fahrenheit degrees (31.44 Fahrenheit degrees) for 6 hours and 33 minutes, as recorded by a digital data logger. There was no previous temperature excursion noted. No additional adverse event information provided.
On Saturday, May 2, patient began to have a fever.  On Sunday, fever continued and arm began to have redness, heat, and swelling.  Patient applied ice, Vick's Vapor Rub, and Voltaren cream which provided some relief.  When patient arrived at clinic on Tuesday, May 5, left arm remained reddened, swollen, and warm.  Symptomatic area measured 70 mm by 70 mm.  When patient was seen by physician on Wednesday, May 6, symptoms were still present but slightly improved.
pt recvd vax;mom noted fever of 104 & rt thigh pain/tenderness almost immed p/vax;crankyness & anorexia;1 1/2cm thigh diam diff w/ R>L,mild tender SQ mass;no color,gait nl;dx hematoma for poss concurrent bacterial infect;tx ibuprophen,bactr
pt recv vax 3OCT95 & 21JAN96 pt devel chicken pox;pt recovered;
sore arm at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient' friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced sore arms at the injection site. The reporter stated that the patient was glad to receive the dose.  The follow-up would not possible as no contact details were available. For tolerance of 1st dose refer case US2021AMR025887. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025887:same reporter
Initial report was received on 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not the sponsor. A 29 year old female patient with a history of humeral muscular dystrophy "autosomal dominant", hypothyroidism and no alcohol or drug use received ADACEL (lot number C2457AA) intramuscularly in the left deltoid on 05 May 2006. The patient's last menstrual period was on 20 October 2005 and estimated date of delivery was 27 July 2006. The patient had the following prenatal testing completed: On 13/Dec/2005: normal serologies, O+, antibody neg., HBsAg neg., Syph IgG neg., Gc/Chlam neg, HIV-NR. On 04/Jan/2006 and 06/Jun/2006 normal ultrasounds. On 10/Jan/2006: Ultrasounds: moderate sub-chorionic hemorrhage which was treated with bed rest. On 02/Mar/2006- ultrasound: 2VC. On 29 July 2006 the patient was induced with PITOCIN at 40 2/7 weeks. She had a vaginal delivery without complications or congenital anomalies. The patient delivered a baby girl and the APGAR score was 5 at one minute and 8 at five minutes. List of Documents held by Sender: none. The reporter of this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, and 2008-04116.
Fever 100-101 degrees for 36 hours, severe joint and bone type pain from head to toe,  chills, inappetence, localized pain at injection site, lethargy, extreme pounding headache for 36 hours
(R) deltoid where MENACTRA vaccine given with induration edema redness. Tx. BENADRYL 50 mg given in office may repeat as needed. Ice, cool compress.
10 yo F arrives at the pharmacy at 10:30 am on 12/26/21 to receive her first dose of the children's (5-11) Pfizer vaccine. Patient waits the 15 minutes time in the pharmacy with no adverse events reported. After 15 minutes I give the patient their Vaccine Card. 5 minutes later patient returns stating nausea as soon as they got to the car. The mom and patient returned to the pharmacy to report the adverse reaction. Patient states she has no trouble breathing just a little nausea and washed out face and lips. I administer 10 ml (25 mg) of Benadryl over a period of 20/30 minutes. After completing the Benadryl and drinking some ginger ale patient was jumping around and dancing and saying she feels 100% better and nothing feels wrong any more. I explaned to the mom that she can go to the ER if she feels it is necessary. She declined that and me calling 911. She said he daughter feels "100% better". Patient left around 11:25am. I explained to the mom that she must speak to the child's pediatrician before getting a 2nd dose of the vaccine and that if she is to get a second dose is cannot be at a grocery store pharmacy it must be in a clinical setting. The mom said she fully understood.