chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurt; small ache/achy; flu-like symptoms; it was a small ache and not as hot to the touch; tired; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to tobacco (smelling cigarette smoke every day for the past 3 to 4 months.) and Cancer surgery (Thyroid cancer surgery) on 29-Apr-2021. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever). In July 2021, PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.            No treatments medications was reported.   This case was linked to MOD-2022-463070, MOD-2022-463121 (Patient Link).
Three hours post vaccine I began to have severe pain in my arm.  This pain was more than muscle soreness typical at an injection site.  The pain was severe and 36 hours later, I still cannot lift my arm.  The pain is sharp and shooting and is more like the pain from a dislocated shoulder.
Second Covid Response to Moderna  I had a very severe reaction to she second Moderna shot (3/4/2.  I went grocery shopping the afternoon after I had my shot at about 11am.  Everything seemed normal, but after 20 minutes I was in an episode of the Twilight Zone .  I bought the wrong products, I also bought several of the same thing.  I bought products I never would have bought and had never purchased before.  Then I got home and was feeling still like I was in the Twilight Zone. (nothing seemed real).  Soon after I fell on the floor and could not get up.  My leg and back would not work.  Then I started to urinate and could not stop.  Buckets came out and every time I tried to get up, I fell completely flat again.  The urination lasted from early afternoon till about 6:30 pm.  Then I went to bed and stayed there till morning when I could get up and walk.  Meantime I had to wash my bedding, 3 pairs of pajamas and seven pairs of under pants.  One of the times I fell, my foot (which was recovering from a burn across my toes) and I jammed it between the wall and the bed, causing a break.  Also the first night I took the shot, I could not get to sleep until 4am (my cat and I were stuck watching Robo Cop till it ended at 4am.  I?m now in a boot-cast, and will get an x ray tomorrow.  I should let you know I take Sartaline HC, 100 mg once a day and Clonazepan, 1 mg 3 times a day.
No adverse events reported post vaccine. 1 st dose on 1/11/21 by public health.  Death 1/31/21 Patient was on hospice for gradual decline.
The patient became dizzy and briefly passed out (for less than 5 seconds).  911 was called upon the arrival of the EMTs her blood pressure and blood sugar was low. Patient was transported to the emergency room.
Patient had visual changes, epigastric pain, and SOB, O2 saturation 88%. Came to hospital. Patient diagnosed with cerebral venous sinus thrombosis.
Pale, fainted required laying down, elevating feet, waiting 20 minutes before standing.
Rash from injection site at right deltoid to right antecubital area. Slight dyspnea.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-OCT-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 48 hours and the lowest recorded temperature was 1 F (1 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
numbness, burning tingling in feet and legs burning in bladder,  Feel like my  central nervous system is in overdrive
Dizziness Little wave of dizziness 100/62 HR62 O2 99%, 100/67 HR 73 Narrative:
Rapid heart rate. My normal heart rate (which has been under control after surgical procedures and with medications) averages 70 bpm at all times. About  10 hours after receiving the Johnson and Johnson vaccine this morning, my heart rate has crept up to 135 bpm and has not yet gone down.
The patient received the second dose of pfizer 16 days after the first dose. no adverse reaction reported.
States she tested positive for COVID 19 at Health Clinic and was quite symptomatic in October 2020.  Vaccinated with Moderna vaccine on Feb 3, 2021 and March 3, 2021.  Currently asymptomatic.  Tested positive on 5/3/2021 before a scheduled procedure.  Tested by a real time PCR assay run on the Hologic Panther for the qualitative detection of SARS CoV 2 virus
In the left arm where the Prevnar was give, the patient experienced redness, swollen, hard knot, severe joint pain, nausea and vomiting, fever up to 104, blood in the urine.
H1N1 vaccine given 0.5cc IM dose needed 0.25cc IM.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 18, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 18, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jun 18, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021.
Patients states at 2 am on 12/2/20 started experiencing a swollen arm, hot to the touch, fever/aches/ chills, temp of 103. Pt called 911 as she felt she was going to faint and paramedics checked vitals. Paramedics advised against going to ER considering all vitals were WNL despite fever. Pt had follow up with MD on 12/2 at 4:30 pm. MD advised pt to come in to be seen for swollen arm but pt refused. Pt was told to take Zyrtec and Benadryl OTC by MD. Fever has resolved. Pt temp is 98.7. Pt still complains of swollen arm due to vaccine.
patient reported adverse reaction to Fluzone HD on 10/19/22: headache, body ache, and site of injection rash, pain, redness and warm at injection site rash. diagnosed with cellulitis after seen at urgent care
Pain and swelling first 2 days at injection site.  Then nothing. Then 1 week later swelling, redness and itching at injection site.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (318  patients received dose from vials beyond 30-day use by date). On Jun 16, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021.
This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 22-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Urticaria appeared on both legs about 4-5 hours after the injections were given and were still present the following day.  She does not have a history of urticaria.
This was my second vaccination and after this vaccination I developed extremely loud tinnitus in my right ear.  To date it is still ragingly loud especially at night.
Injection site erythema; slight arthralgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (slight arthralgia), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Injection site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (slight arthralgia) and FATIGUE (Tiredness). On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site erythema). On 07-Apr-2021, ARTHRALGIA (slight arthralgia) and FATIGUE (Tiredness) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site erythema) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information was provided.
headache (day 2 - now), body aches (day 2 - now) , fever on and off (day 2 - now), runny nose, rash from head to toe (day 2) and now is dormant
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid treatment from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331394 same reporter/patient, different product/AE;
Developed weakness right side that has since resolved.  Later, 12/20/2006 developed pain and muscle spasm upper right trunk.  On exam 2/28/2007 had mild decrease right bicept reflex, full strength.
02/28/2006 arm became swollen.  Next day mom called, doctor ordered Pedia Pred- arm red, tender, little less swollen - mostly local reaction.  No loss range of motion.  Patient had 101 degree temperature the first night after DTAP shot.
Patient received PNEUMOVAX around 4pm on 11/23, on 11/24 morning patient called stated red and swollen, not painful was instructed to put ice and if tolerated take Ibuprofen or TYLENOL. Red, swollen when patient presented to pharmacist later in afternoon 11/24, advised patient to see MD, at walk in clinic MD Physical examination: Erythema, swelling, hot to palpation. Was prescribed antibiotic and assessed as cellulitis.
Patient came to pharmacy 3 days after getting vaccine with swollen elbow. Looked to be a large cyst of some sort, about 5 inches long and 3 inches wide.
Pt developed polymyositis with weakness which began 11/7/01. Follow up letter from reporter dated 11/16/2001 states that "After further investigating the PCP discover that this pt was not experiencing adverse event onset due to Hep A. VAERS was notified immediately."
Information has been received from a health professional concerning a 8 year old female pt who on 15-AUG-2000 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 21-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
loss of feeling in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (loss of feeling in right arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L208) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE ANAESTHESIA (loss of feeling in right arm). On 18-Jan-2021, VACCINATION SITE ANAESTHESIA (loss of feeling in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-118044 (Patient Link).
Approximate 25 minutes after my second Moderna shot in my left arm I started experiencing tinnitus in my left ear only, that lasted for 6 days.  By day 5 it was beginning to lessen and disappeared on day 6
Information has been received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with 7 doses of (Oka/Merck) VARIVAX, lot # K007781, expiration date 28-MAY-2016 (dose and route not  provided). The temperature excursion with (Oka/Merck) VARIVAX was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
On day 10 following injection, red rash at injection site, (shoulder) about 2" diameter.  Also rash on both hands, especially both forefingers, like poison ivy: itchy, red , some swelling, also other spots scattered on hands.  Treated with Cortisone cream On day 14, the redness at injection site measured about 4" x 6" - not itchy or rashy, more just a red area By day 17, symptoms were gone.
Patient experienced migraines, fever, abdominal pain, sweating and felt stabbing pains for 7 & 1/2 hours.
Have a throbbing HA starting day three after vaccine to present time; This is a spontaneous report from a contactable pharmacist, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 07Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. The patient had known allergies to penicillin and mushrooms. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included CIALIS, METFORMIN, and PROTONIX, all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 14Feb2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 09Mar2021 at 08:00, the patient had a throbbing headache (HA) starting day three after vaccine to present time. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with NAPROXEN (MANUFACTURER UNKNOWN) 550 one tablet twice a day (bid). Since the vaccination, the patient had been tested for COVID-19. On 10Mar2021, the patient underwent COVID-19 test (reported as care) via nasal swab and the result was negative. The clinical outcome of the event have a throbbing HA starting day three after vaccine to present time was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Home AG: positive; Home AG: positive; HA; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Dec2021 (Lot number: FF2589) at the age of 50 years as dose 3 (booster), single, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovering" and all described as "Home AG: positive"; HEADACHE (non-serious) with onset 10Jan2022, outcome "recovering", described as "HA". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, headache.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation, Vaccination failure, Covid 19, Headache and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates, two doses of PROQUAD (Merck) (dose and route of administration were not provided; either from lot # L007231 with expiry date on 09-MAR-2016 or from lot # L017140 with expiry date on 13-NOV-2016), that had been improperly stored were inadvertently administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
Pt HAD HIVES ON LEGS STOMACH AND BACK AFTER WAKING 14 HOURS AFTER FLUSHOT. I INSTRUCTED HER TO TAKE BENADRYL AND WATCH FOR FURTHER SIGNS OF ANAPHYLAXIS AND TO TREAT AS AN EMERGENCY IF SIGNS WORSEN. I ALSO ASKED IF THERE MAY BE ANYTHING ELSE COINCIDENTAL THAT MAY HAVE TRIGGERED, SHE WOULD THINK ABOPUT AND LET US KNOW...
Red spot appeared on left arm in shot area two days after first dose of vaccine. The redness began to fade but has returned. With the recommendation of a nurse friend, I drew a line around the affected area and the redness has grown past the line. The size of the redness is about 3.5 inches wide and 1.5 inches tall. The area is also very itchy. It is concerning because the redness had almost dissipated and now has come back over a week after the first dose.
About 6 hrs after the shot I had the worst headache of my life that lasted over 12 hrs. Doubt if I will ever take another flu shot.
aBOUT 5 HOURS AFTER RECIEVING SHOT I BEGAN TO ACHE ALL OVER APPROX8 HRS AFTER SHOT i BEGAN WHEEZING BADLY LIKE I WAS DROWNING IN FLUIDS AND I GOT CHILLS AND FEVER I WAS SHAKING SO BAD i COULD NOT EVEN TALK  I GOT UNDER ELECTRIC BLANKET ON HIGH AND COVERED UP, EVEN MY HEAD UNDER 4 MORE QUILTS.2 DAYS LATER I GOT A COLD THAT I STILL HAVE AND MY BODY IS STILL ACHING ALL OVER.WILL PROB SEE DR TOMMORROW  tHIS IS THE 2ND TIME TO TAKE THE FLU SHOTAND THE SAME REACTION BOTH TIMES COLD LAST ABOUT 6 WEEKS