chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got sick; Broke out in a sweat; Was weak; Fell from being weak; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills). At the time of the report, ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Began with 4 spots on chest, now 60 lesions on entire body.  Febrile.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 04-NOV-2012 12:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pimple spots developed about 3:30 today, with fussiness since this AM; since playing in water today. Mother reports that patient is teething and drooling a lot.
Significant flu-like symptoms: fatigue, chills, nausea, muscle aches, headache, no appetite, low-grade fever (101 degrees when checked). Symptoms started about 20 hours after getting the vaccine. Symptoms started improving after 8 hours; weakness and low appetite continued until about 48 hours after receiving vaccine. Tylenol taken once during course of symptoms for headache relief.
I21.4 ACUTE NON ST ELEVATION MI 4/24/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/24/2023 HX OF CABG I21.4 ACUTE NON ST ELEVATION MI 4/24/2023 SHORTNESS OF BREATH
Starting 8pm that evening sudden fever, extreme weakness, intense body aches, intense chills,  intense bone, muscle, vein pain uncontrollable tremors , spasms, body tremors.   intense headache,   freezing despite many blankets.  Worst pain in my entire body I have ever felt in my life!! day 2  still fever despite taking Motrin.   weakness , body aches.   In bed all day.    day 3 still fever...  feeling of sudden extreme drowsiness, lightheadedness.   nausea ...    woke 3 am intense pain in left ear.  temp.99.5 took more Motrin for pain. day 4  headache still, weakness ,  fullness feeling in head and ears..  left arm soreness... still left ear discomfort...  feeling scared ....  feel like my body was poisoned.    have not had so much as a cold in 5 years now I am hardly functional.    feel like I should go to hospital or urgent care if my body temperature and headache ... disturbing unexpected symptoms doesn't improve soon but wanted to get this info in to document as this is first time I physically felt able to even do this.
P/receiving influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site, rxn area was 10-20 cm in size;
Vaccine was administered at Nursing Facility.   Patient is an 89-year-old female with prior medical history of CVA with dysphagia, history of possible dementia, GERD, hyperlipidemia, and a pacemaker.  She is a resident from town.  She was sent for hypotension with a blood pressure of 90/52, tachypnea respirations of 54, possible aspiration pneumonia.   Status post Covid vaccine earlier today.  History is limited as patient is nonverbal on my exam.  Death within 24 hours of vaccination
W/in minutes p/vax pt pale, collapsed, weak pulse, resp dec, inc pallor, slow response to lying down/02; generalized hypotonia; vomited x 2; pallor & tone dec; BP dec; IMP: ?vasovagal vs collapse-hypotonia rxn; admit to hosp for observation
Saturday 05/01/2021 within 45 minutes I started to feel  muscle aches in my upper back/neck area. I was able to go about my daily activities but didn't feel well. I took a hot tub in the evening and my husband massaged my back/neck before going to bed around 9:00pm. Sunday my muscles felt better. Monday I had a sore/red spot on my forehead at the hairline and a headache that radiated down the left side of head/neck. Tuesday the sore spot and headache continued. Wednesday woke with swollen lymph nodes on left side around the ear and neck with a headache, by that night the right lymph nodes were starting to get tender. Thursday woke with tenderness in left/right lymph nodes, swelling and headache were slightly better.
A week after my Moderna booster, I began experiencing intense itching all over my body, like an itch beneath the surface that I couldn't scratch. After a few weeks of this I finally took Zyrtec and within two hours was covered in hives. I was put on Prednisone along with Zyrtec. Only when I stopped the Zyrtec a week later did my hives begin to abate. I have had several recurrences and three rounds of prednisone which may or may not help. Zyrtec definitely aggravates. Claritin didn't seem to help but also didn't aggravate. Now adding famotidine with no aggravation thus far. The hives cover my entire body at times and move around rapidly. Topical Clobetesol helps but refill is being denied by my insurance company. Referred to allergist and waiting for appointment on 4/19/22.
I got was getting a CT scan and had the dye in my system.  Then on the same day I got my Covid-19 shot.  I got super sick for about a week.  I was running a fever.  I went to the doctor about this.  She said that I should have not combine the two.
This spontaneous report was received from a healthcare worker refers to a 4 year old patient. On 20-MAY-2014, the 4 year old patient was inadvertently administered with GARDASIL, 0.5 ml, intramuscular. No adverse effects reported. No PQC. No further AE information was provided. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On 7th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the left upper arm and had no problem except for some soreness around the injection site for 2 to 3 days. The patient had no primary physician. This case has been linked to the case US2019GSK016957, reported by the same reporter.
Case number PHEH2015US026835 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 55-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked he temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Patient was admitted to the hospital on 04/29/2021. And was discharged with Care on 5/5/21 and expired on 5/26/21.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy:sulfa" (unspecified if ongoing); "Allergy:Penicillin" (unspecified if ongoing); "Allergy:cyclosporines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was used from 17Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever 102 that evening that improved to 101 at the time patient reported 24 hours later.   Patient also experiencing pain in left shoulder and loss of range of motion.
Six hours after I received the vaccine the most intense pain I've ever felt in my life took over my entire body and has not stopped for a moment 20 hours later. It's particularly bad in my legs, knees, and elbows. There's also a fever but the pain is much worse.  I have a high pain tolerance but I'm not kidding when I say this is unbearable. Breaking a bone hurts less. Actual COVID hurt less. This is agony.
Had the vaccine in my right arm at 1:30 on Saturday March 6.  Felt fine throughout the day and evening with just a little arm tenderness and slight headache.  Felt feverish, shivering, achy, sensitive skin throughout the night.  Woke at 7 a.m. and as I passed a mirror, noticed a large lump behind my left armpit (not sure what to call this area--back of shoulder/arm), the size of 1/2 tennis ball.  Not painful, but alarmingly large, having had nothing there the day before. Saw my Dr. on Monday March 8.  She prescribed a round of prednisone and an ultrasound.   Ultrasound on Tuesday March 9 described as "lipoma-like mass", but could not explain sudden appearance so MRI recommended.  (Appointment scheduled for Thursday March 28 for MRI) Re-visited Dr. on Friday March 12, as even after prednisone, swelling seemed slightly increased.   Dr. described as "orange sized". Still not painful, but uncomfortable and very tight.  Dr. suggested I visit a surgeon for further investigation.   Sheduled to see surgeon at Hospital today March 16
neck pain / mimicking soreness / still has the pain on the left side of her neck; strain; head feeling heavy to pick up off the pillow'.; This case was reported by a other health professional via sales rep and described the occurrence of neck pain in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received the 2nd dose of Bexsero and Influenza vaccine Quadrivalent 2020-2021 season. On 10th October 2020, 3 days after receiving Bexsero and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting ibuprofen, the patient experienced neck pain, strain and heaviness of head. The patient was treated with ibuprofen. On an unknown date, the outcome of the neck pain, strain and heaviness of head were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, strain and heaviness of head to be related to Bexsero and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the dose of Bexsero and Influenza vaccine Quadrivalent unspecified season and experienced neck pain mimicking soreness or a strain as well as her head feeling felt heavy to pick up off the pillow',which was not recovered. The patient has been taking Ibuprofen. has the pain on the left side of her neck. Till the time of reporting the pain on the left side of her neck was not recovered. The reporter consented to follow up. No further information was available
Mother and father report to health dept with patient on 8/7/18 at 9:13am. Mother is concerned about redness and swelling on child's upper left arm (deltoid area). Grandparent's noticed redness and swelling Friday afternoon 8/3/18. Child woke up Saturday complaining of pain in left arm and had some "spit up", not enough to be called vomit according to mother. By Sunday, redness and swelling had intensified. On Monday the redness and swelling started to diminish with the border becoming more noticeable. Some warmth present at site today with slight redness, a darker red at border edges measuring 6 1/2 inches wide with 4 3/4 inches long. Mother states she administered acetaminophen during the first 24 hours and BENADRYL liquid on Saturday and BENADRYL cream Sunday night. Nurse advised mother to continue to administer pain medication as needed and as instructed on package. Advised to apply a cool washcloth ten minutes four times a day. To seek emergency care and medical care as needed. Informed that health department will follow up later this week for update on patient's status.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 2 months old female patient who experienced expired PENTACEL vaccination was given, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; HEPATITIS B VACCINE for Immunisation; and ROTATEQ for Immunisation on an unknown date (Batch number, expiry date, dose, dose in series, route and site of administration were not reported). On 04-Sep-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5418AA, Diluent: C5230AA and expiry date: 02-Sep-2018) via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
I have had an almost constant headache for the past several months. I cannot be absolutely certain when the headache started, but I know it was near the end of September. It IS possible that the headache started before my last COVID shot. I am not generally a headache person and I am in otherwise good health.  My doctor says that my symptoms sound like a tension headache.  I feel stress, yes, but no more than I have had over the last few years. I feel an almost constant pressure in my head. Sometimes, upon a change in position, the pressure builds up momentarily to the point where I need to pause and close my eyes. My ears also have pressure in them. My doctor has checked for a sinus infection and prescribed antibiotics just in case, and I have had an MRI which no brain abnormalities and indicated that my sinuses are clear.  Medication like ibuprofen *sometimes* provides temporary relief, but the pressure always returns.  It's not debilitating, but it is frustrating.  I just recently started taking loratadine to see if that helps -- maybe the headache is due to seasonal allergies -- but it seems like a long time for that to be the case. So far, the loratadine has not helped.
I had the 1st injection with minimal soreness in R arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 08:45 (Lot number: EN5318) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "known allergies : Fungus" (unspecified if ongoing); "known allergies : Mold" (unspecified if ongoing); "known allergies : Egg plant" (unspecified if ongoing); "known allergies : Wheat" (unspecified if ongoing); "known allergies : String" (unspecified if ongoing); "known allergies : Bean Chocolate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTH; ALLEGRA; BENZONATATE. Past drug history included: Azithromax, reaction(s): "known allergies: Azithromax". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "I had the 1st injection with minimal soreness in R arm". Relevant laboratory tests and procedures are available in the appropriate section.Additional information: Concomitant medication(s) included: LOSARTAN (Dose: 50); HYDROCHLOROTH(Dose: 12.5); ALLEGRA; BENZONATATE(Dose:100). No follow-up attempts are possible. No further information is expected.
Next morning after receiving Td, client experienced some swelling and soreness in upper left arm, which lasted for 3 days. Today, 01/18/05, the patient only complains of slight itching where the swelling occurred.
This was my second vaccination. First was 4 weeks earlier and I had no adverse reaction other than pain/ache at injection site. Second shot started off similar--arm pain  The following issues began about 12 hours later and were completely gone within 36 hours:  Chills, fever, overall body ache, fatigue, headache. Started around bedtime, worsened for several hours. Fever and chills had subsided by morning (8:00 am). Body ache, fatigue lasted through the day and at bedtime on the second night. All symptoms gone by the next morning.   Felt fine 48 hours after this shot other than a minor amount of soreness at injection sit.
fell shouldn't drive car; body ache; chills; maybe fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever). At the time of the report, FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) outcome was unknown.            No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-024150 (Patient Link).
HANDS, FEET AND ANKLES BROKEN OUT IN HIVES.  RANDOM HIVES ON ARMS AND TRUNK.
left arm, shoulder and neck pain; left arm, shoulder and neck pain; left arm, shoulder and neck pain; Tingling in left arm; tiredness an fatigue; This is a spontaneous report from a contactable consumer reported for a female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: Unknown, Expiration date: Unknown) via an un-specified route of administration, as single dose for covid-19 immunisation on an unspecified date. The patient medical history and concomitant medication was not reported. On an unspecified date, the patient experienced left arm, shoulder and neck pain tingling in left arm A little bit of tiredness a fatigue. The event considered non serious. The outcome of the events was unknown.
Rash: red papular with some vesicles on arms, legs and face and spreading. Prob. chicken pox post vaccine.
Facial shingles. Started Sep 2 with rash on forehead and sensitive skin on left side of forehead and around left eye and upper cheek and scalp. Difficulty sleeping. Diagnosed at Urgent Care as shingles on Sep 5. Blistering started around same time. Prescribed Valacyclovir1000mg x 3 times daily for 7 days. And lidocaine cream 5% for pain. Saw opthamologist on Sep 8 to check for any damage to cornea. No issue noted. Blisters crusted over by Sep 13/14. Currenly sensitive scalp and left cheek and periodic headackes. Still difficulty in sleeping.
Expired Moderna vaccine administered to patients; The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 5-Apr-2022. It was reported that the administration occurred from 6-Apr-2022 to 9-Apr-2022.  The vial had not undergone any temperature excursions. Patients had not reported any adverse reaction No treatment medication information was given.   This case was linked to MOD-2022-537580, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538697, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676 (Patient Link).