chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching rash; Bruise mark at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruise mark at injection site) and RASH PRURITIC (Itching rash) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CONTUSION (Bruise mark at injection site). On 03-Feb-2021, the patient experienced RASH PRURITIC (Itching rash). At the time of the report, CONTUSION (Bruise mark at injection site) and RASH PRURITIC (Itching rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nausea, Fever 102, chills, body aches, vomiting, arm soreness, axillary lymph swelling in injected arm, sweating, redness at injection site, headache and fatigue.
p/vax pt cried for a few min then stopped crying while still @ hlth dept;pt fell asleep in car;mom gave advil;mom noted both upper & lower eyelids rt & lt swollen like grapes-swelling gone w/in 1hr;slept x6hr;woke up & OK;did not see MD
Severe pain in shoulder down arm. Muscle atrophy and nerve damage. Seeked several doctors and came to the conclusion the cause was from flu vaccine. I have recovered since then, but would like to know if it is safe to take the flu vaccine as I get older?
Fever, Fever continues 2/27 & 28/2021; now resolved Narrative:
patient received second dose of Imovax series on 10Dec2019 instead of 07Dec2019 as scheduled; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who received RABIES (HDC) VACCINE [IMOVAX RABIES] and it was reported that the patient received the second dose of Imovax series on 10-Dec-2019 instead of 07-Dec-2019 as scheduled (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 10-Dec-2019, the patient received the second dose of suspect RABIES (HDC) VACCINE (lot number not reported) via unknown route at an unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was not reported if the patient had any adverse event.  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 and Module VI of the 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.
multiple outbreaks of herpes zoster; Post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently the patient was treated by a physician for the following injuries resulting from Plaintiffs ZOSTAVAX use: multiple outbreaks of herpes zoster and post (e) herpetic neuralgia. The outcome of the events was considered as not recovered. Causality assessment was related.
wasn't feeling great; fever 101.7 F; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like wasn't feeling great, fever of 101.7 f.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) wasn't feeling great, fever of 101.7 F.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) wasn't feeling great, fever of 101, 7 f was unknown.
antibody test done 18Jan2021 and the results were negative; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on 18Dec2020. Patient received the second dose of the Pfizer vaccine on 08Jan2021 and had an antibody test performed on 18Jan2021. The results were AB IGG negative response. Patient asked "Have you encountered this in your trials? Is there a point of contact that I could talk to about my immune response? I take no medications, have no significant medical history. I think it would be important information for me and my patients to know if some people just don't make antibodies to COVID-19." The outcome of the event antibody test/negative was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150: US-009507513-1701USA007912: Original Case : 1701USA007906: US-009507513-1701USA007922: Original Case : 1701USA007910: US-009507513-1701USA007881: Original Case : 1701USA007910: US-009507513-1701USA007882: Original Case : 1701USA007910: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
A few hours after getting the PREVNAR 13 shot her left upper arm became very red, and swollen, was very itchy. Did not call or come to the clinic until 5 days later. Red area measures 4 1/2 in x 4 1/2 in today 6/19/17. Denies fever or any shortness of breath.
6 days p/vax devel 2" erythematous area @ site inj, non tender;
Information has been received from a registered nurse concerning an approximately 4 year old white male with no known drug allergies who on 8/12/04 at 3:00 PM was vaccinated SC with a first dose of varicella virus vaccine live (lot # 648086/0098P). Suspect therapy that day at 3:00 PM included a first dose of MMR (lot # 646590/1051N) administered SC. Subsequently, the patient experienced a reaction. The reporter did not know the nature of the reaction. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. Follow up information indicated that the adverse event was unknown. No additional information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medication were not provided. On 19-MAY-2014, the patient was inadvertently administered MMR II, subcutaneously (dose and lot number were not reported) which expired on 17-MAY-2014. No adverse effects were reported. Additional information has been requested.
Few minutes after receiving vaccination the patient became pale and has experienced brief loss of consciousness (~5 seconds). After regaining consciousness, drinking some water, and approximately 15 minutes of additional siting time, the patient stated that they were feeling ok.
I started feeling numbness on my mouth, face, and tingling all over my body. It felt like I was electrocuted.
This spontaneous report has been received from a consumer referring to an unknown number of patients (unspecified ages and genders). The patients had no pertinent medical history, drug allergies/reactions or concomitant therapies reported. The reporter was told by a nurse practitioner, that other unspecified patients have had occurrences of fainting (Syncope) similar to the one that happened to her daughter (captured on MARRS# 1701USA001687) after being vaccinated with GARDASIL 9 regimen for prophylaxis (lot #, expiration date, dose, and anatomical location were not reported). The causality assessment between faint and the suspect product was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001687:
Medical Examiner at time of autopsy ordered Covid testing 06/30/2021 08:30 Nasal swab- reported SARS-CoV-2 RNA detected and confirmed at lab.   Cause of death: Complication of Covid-19  Other significant conditions:  Chronic A-Fib, HTN, Chronic systolic heart failure, COPD
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 20-year-old female patient received 1st, 2nd and 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced increased energy (burst of energy), with outcome of unknown. Additional information included: Reportedly, patient had 3 doses of the Pfizer COVID-19 vaccine. Patient experienced side effects after each dose. One of the side effects, she had after each dose, was a burst of energy. She figured there must be something to this, because she was not the only one who said this. She felt twenty years younger. She cleaned her whole house, all 2800ft². She  never got tired. All three doses gave her this energy. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Started experiencing pain in toes first on the right foot then on the left foot that spread into the bottom of feet. The first pain was noticed in middle toe of the right foot about 10 days after the first dose of the Pfizer COVID-19 vaccine as administered. The pain gets bad after about a mile-long walk so that I can barely step on my feet. Before the vaccine, I ran 6 miles every day.
(L) posterior arm reddened, swollen at site of vaccine. T-100. Dx: cellulitis, treated with cephalexin.
ACHES , LOW GRADE FEVER, CHILLS, HEAD ACHE, PAIN AT ARM INJECTION SITE,  FLU LIKE SYMTOMS
Pt's mother claims that he regressed in his speech and language development after MMR administration at 15mo. Prior to vaccine he said mama, dada, hi, all done, bye. Speech dev. regressed and he stopped saying above words. Currently in speech therapy
pt recv vax;found in car asystolic & apneic on 17may95; was rushed to hosp p/ attempted resuscitation by paramedics;
Began with myokymia (twitch) in left eye which persisted for almost 2 months.  Has since spread to right eye.  Now experiencing blurred vision, double vision, and random muscle twitching in limbs.
I had a fever up to 101.9 degrees that lasted from 12-30 hours after the vaccine.  I chose to not treat it and let my body respond on its own. A headache was present on and off between 12 and 30 hours after the vaccine.
INR dropped from a normal of 2.9 to 1.9; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement in 2004. Concurrent medical conditions included Fruit allergy (Allergy to strawberry), Drug allergy (Allergy to steroids), Penicillin allergy, Fruit allergy (Allergy to cranberry) and Drug allergy (Allergy to narcotics). Concomitant products included WARFARIN and VITAMINS NOS for an unknown indication.   On 05-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9). The patient was treated with LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) ongoing since an unknown date for INR decreased, at a dose of UNK, q12h. In March 2021, INTERNATIONAL NORMALISED RATIO DECREASED (INR dropped from a normal of 2.9 to 1.9) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, International normalised ratio: 1.9 (Low) 1.9. Normal is around 2.9. In March 2021, International normalised ratio: 2.9 (normal) 2nd week back to 2.9, 2.7 (Low) 3rd week 2.7 and 1.9 (Low) 4th week back down to 1.9. In April 2021, International normalised ratio: 3.0 (Low) 5th week 3.0, 2.4 (Low) 6th week 2.4, 3.2 (High) 7th week 3.2 and 4.9 (High) 8th week 4.9. In May 2021, International normalised ratio: 4.7 (High) 9th week 4.7 and 1.5 (Low) 10th week 1.5.         The patient 's cardiologist told her to take her INR weekly instead of every other week until her next dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up document received on 11-May-201 contains updated patient details, medical history, concomitant medications, lab data, treatment information and second dose details.
This spontaneous report as received from a female consumer of unknown age refers to herself. The patient reported that she received a dose of ZOSTAVAX "4 to 5 days ago" (on approximately 17-APR-2014), (dose, route, lot # and expired date were not reported). The patient reported that since receiving the vaccine (time frame for the onset of the event not specified), on approximately 17-APR-2014, she was experiencing itching, tingling and numbness. The patient stated she was not "feeling well" and would be contacting the pharmacy where the vaccine was administered. The patient did not seek medical attention. The outcome of adverse events was reported as not recovered/not resolved. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K008140 with expiration date: 30-MAR-2016 and lot # reported as # L002048 with expiration date: 09-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Client complained of achiness, malaise, headache that started that night and went into the next day. Client complained of a fever of 101 that lasted approximately 5 hours; unrelieved by Tylenol. Client had a golf ball sized swollen lymph found on 9/12/19 by client; was resolving on 9/13/19 at 8:45 am when examined by M.D. and nurse (myself), no longer visible, just slightly swollen and tender to the touch.
I am a carcinoid cancer patient with Fibromyalgia I am experiencing sever swelling in my joints finding it hard to walk or function and the depression is overwhelming I am associating back to the vaccines from Monderna that is the only thing that makes sense. Moderna vaciines and boosters crippling arthritic swelling and pain along with depression that is not getting unmanageable. I have a history of Carcinoid cancer and Fibromyalgia I am in full blown crisis.
Pt recv vax on 1/19/98; on 8/15/98 pt exp multiple vesicle type lesions from neck to right ear to right cheek down chest w/ pain.On 8/17/98 pt saw M.D.; tx=Augmentin,Tylenol&Acyclovir.On 8/22/98 pt exp paralysis of right face;dx=Bells Palsy
second  Pfizer vaccine vaccine was administered the patient developed a purple petechiae rash started developing on her left hand. NP ordered 25mg of Benadryl to be administered PO for the patient and to stay in observation for the next 30 min.  The 30 min were observed by the LVN the patient's rash was clear and patients vitals are as fallowed B/P 116/67 Resp 18 O2 94. The patient said she was feeling well no sighs of SOB .
Bell's palsy type reaction - (R) sided facial paralysis. Currently being treated w/ MEDROL Dose pak.
Pt had hoarse cry not many days p/shot; MD had given perfect hlth @ 6wk check-up; died of SIDS on 2DEC;
Began to have  symptoms of an MS relapse. Symptoms are buzzing in both legs. Ongoing since last week.
"I'm dizzy" no difficulties observed. Idalberto Mesa (fa.) notified and is picking up Yolexis. Spoke with father re: sis to report to MD or EMS. Father took her home at 11:15am.
mildly sore left arm; mildly sore left arm; received 4 shots of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 shots of the Moderna vaccine), the first episode of PAIN IN EXTREMITY (mildly sore left arm) and the second episode of PAIN IN EXTREMITY (mildly sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 036B21A, 030M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Autoimmune Blood Disorder). Concomitant products included ATORVASTATIN, MAGNESIUM OXIDE, FISH OIL, CENTRUM VITAMINTS, PANTOPRAZOLE, FINASTERIDE, TAMSULOSIN, AMLODIPINE, FERROUS SULFATE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 3 dosage form. On 10-May-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 4 dosage form. On 12-Jan-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 4 shots of the Moderna vaccine). On 15-Apr-2021, the patient experienced the first episode of PAIN IN EXTREMITY (mildly sore left arm). On 12-May-2021, the patient experienced the second episode of PAIN IN EXTREMITY (mildly sore left arm). On 10-May-2021, EXTRA DOSE ADMINISTERED (received 4 shots of the Moderna vaccine) outcome was unknown. On 13-May-2021, last episode of PAIN IN EXTREMITY (mildly sore left arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: others (Negative) negative. In June 2021, SARS-CoV-2 antibody test: others (Negative) negative.         This case was linked to MOD-2021-237330, MOD-2021-238058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Alternative contact number updated and patient demographics added.
pt recvd vax; not feeling well; had fever; now sore throat; some runny nose; cough; exposed to strep 6nov; throat cx = not grp A beta strep;
Information has been received from a registered nurse concerning a 52 year old retired female with no known drug allergies who on 12-JUN-2007 at 11:40 am was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (Lot #655288/1174F).  Illness at the time of vaccination included chronic bronchitis.  On 12-JUN-2007 the post vaccination the patient experienced swelling and warmth in most of her right upper arm.  It was reported that on 13-JUN-2007, the patient reported back to the clinic.  His right arm was "edematous" from the shoulder to the elbow, red, and warm to touch.  The patient also reported pain from the shoulder to the tips of the fingers.  Approximately one week later, the patient recovered.  Additional information has been requested.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 5/11/2021. Patient brought to ED for acute confusion on baseline dementia and resp sx including cough and dyspnea that started yesterday; was covid + yesterday at outside behavioral hospital. Reported to be hypoxic at 88% today at the outside facility as reported by that facility but was 95% on RA when EMS checked on arrival. He was found to have a UTI due to ESBL E coli and initially received merrem and was transitioned to macrobid to complete treatment. He was found to have severe dysphagia. The patient's wife made decision to allow comfort feeds. He did develop aspiration pneumonia and respiratory failure. Wife subsequently decided to focus on comfort care and transition to inpatient hospice. Patient passed on 11/03/2021.
Pain in arm - realized when I woke up the morning after taking the shot. Pain continued through the day, then waned to milder the next morning.   Fatigue - lasted a few hours during the late morning of the day after the vaccine. Accompanied by a little chill. No fever.   This was my second vaccine. No adverse events upon receiving my first dose.
Dose given at 1502. Patient reports "throat tightening/restricting" at 1515. Epi 0.3mg given at 1519. No improvement of symptoms after 5 mins. Pt brought to ER for further evaluation.
Patient was told and documented as receiving Jansen vaccine but was given Moderna vaccine in error. Patient was called and no ADRs noted immediately after vaccination.
Case completed MOderna Covid vaccine series on 3/29/21, then was admitted to the hospital on  8/23/21 for treatment of Covid pneumonia.