chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6.5x5cm area of induration on L delt injection site. States "that it was much larger over the weekend". Area of demarkation noted measuring 16x9cm. Area w slight redness, no edema noted. Pain was described as 3/10 at its worst.
Did not receive second dose; Redness at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included IRBESARTAN, CARVEDILOL and CLONIDINE for Hypertension, ASPIRIN [ACETYLSALICYLIC ACID] for Prophylaxis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 18-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) 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.   Treatment information was not provided.
it was hot; Break out a little bit; Arm began to itch, it itched so bad; It was a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red). At the time of the report, VACCINATION SITE WARMTH (it was hot), RASH (Break out a little bit), INJECTION SITE PRURITUS (Arm began to itch, it itched so bad) and INJECTION SITE ERYTHEMA (It was a little red) outcome was unknown.        The action taken with 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-020870 (Patient Link).
Right leg warm and red at vaccine site. Given TYLENOL. Left leg had a knot at vaccine site. Vomiting, unconsolable. 1 day post injection. Cellulitis treated with Cephalexin (upper rt thigh). Trimethoprim given in office.
WBC's are also very low; she didn't get antibodies; States her immune system is so weak; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included sjogren's syndrome from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing States her rheumatoid syndrome is caused by that and she was diagnosed at age 27 years. Concomitant medication(s) included rituximab (RITUXAN) taken for rheumatoid arthritis from Oct2020 to an unspecified stop date. On an unspecified date the patient experienced WBCs are also very low, she didn't get antibodies and states her immune system is so weak on an unspecified date.The patient underwent lab tests and procedures which included: she has no B-cells, WBCs are also very low. She had antibody testing done 03JUN2021 for SARS-COV-2 Immuno essay, the results were neg. She had a 2nd antibody test (IGG) on 09Jun2021, and the test was also neg. States her sister has triple neg breast cancer and had no antibodies either following chemotherapy, not sure if she had the Pfizer Covid vaccine or Moderna. Caller is also waiting to find out her T-cell level. Caller states she just wanted to call and report that she got the Pfizer vaccine back in Apr2021 and was fine with no side effects, it was smooth with just a sore arm. State she got her last one 3 weeks later in May2021 and then started reading. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt became lethargic and pale 5 minutes after vaccines; hypotonic, bradycardic. EMS activated. Started on O2 and stimulated baby. Transferred to ER then to tertiary care.
pt recv vax & exp Bell's palsy 3 days p/vax;f/u info indicated that pt had lt facial droop 2 days p/vax & sx persist about 2wk;MD indicated that doubted but was not sure that sx caused by flu vax;
Information has been received from a physician concerning a female who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) on an unspecified date. Subsequently the patient developed rash on forehead after getting ZOSTAVAX (Merck). At the time of reporting she was recovering. The patient sought unspecified medical attention. Additional information has been requested.
lower back muscle soreness; fever; chills/chattering teeth; This is a spontaneous report from a contactable other hcp. This HCP reported for himself that a 31-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9263), dose 1 intramuscular, administered in Arm Right on 26Jan2021 16:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 19:00, the patient experienced lower back muscle soreness; fever and chills/chattering teeth. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on 31Jan2021 from 7 pm until 02Jan2021 afternoon,I had a fever, sars-cov-2 test: negative on 01Feb2021. It was reported that on 31Jan2021 from 07:00 pm until 01Feb2021 afternoon, patient had a fever of 102.3 degrees F with chills, chattering teeth and lower back muscle soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The clinical outcome of all events were recovering.  Follow-up attempts are completed. No further information is expected.
Patient reported fever, chills, fatigue and large rash on lt upper arm the following day.  Yesterday rash had increased in size was very painful  extending to axilla and warm.  Denies any further fever but still fatigued with chills
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
pt has a history of guillane barre. Pt recieved a flu shot instead of a Pfizer bivalent booster dose
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant products were not provided. Treatment medications were not reported  Company comment: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported; who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. Caller mentions they know that 1 senator from the state of Massachusetts tested positive for COVID-19 even after getting 2 shots and the booster form one COVID-19 vaccine. Clinical course and treatment details were not provided. Caller does not provided consent for follow up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported; who experienced unexpected event of COVID-10 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. Caller mentions they know that 1 senator from the state of Massachusetts tested positive for COVID-19 even after getting 2 shots and the booster form one COVID-19 vaccine. Clinical course and treatment details were not provided. Caller does not provided consent for follow up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Headache and fatigue the day following injection.  Took (2) 500mg Tylenol around 9am the day following injection to relieve headache, felt fine (no headache or fatigue) about an hour after taking Tylenol.  Took multivitamin and Zyrtec normally at bedtime (around 9:30pm) and adverse event has not returned.
a moderate fever (99.9), a mild fever that came and went; fatigue, fatigue but not as bad; a headache, a headache that was mild but had not gone away; swelling at the injection site; muscle pain; This is a spontaneous report from a contactable consumer (patient) received. A 34-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 08Jul2021 01:15 PM (Batch/Lot Number: Unknown Unable to locate or read the details) as dose 1, single at the age of 34-year-old for covid-19 immunisation. Medical history included panic disorder, autism spectrum disorder, ADHD (attention deficit hyperactivity disorder), and PTSD (post-traumatic stress disorder), all from an unknown date. Concomitant medications included multivitamin; aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX); ascorbic acid (VITAMIN C), all taken for an unspecified indication. The event onset date was 08Jul2021 03:30 PM. The patient had a moderate fever (99.9), fatigue, and a headache the first day. She was on the second day (as reported) and had a mild fever that came and went, fatigue but not as bad, and a headache that was mild but had not gone away. She also had swelling at the injection site and muscle pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Lab test included a moderate fever (99.9) on 08Jul2021. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
04/21/06 child came home from a camp out. Had bumps on her. On exam had a few typical bug bites but had about 26 lesions that appeared to be varicella. No fever, Lesions on trunk, buttock and legs. Spoke to mom this am 4/24/06 child seems fine. No more lesions. No change in the rash from Friday 4/21/06. Taking Benadryl for itching.
Patient's arm was sore for about 3 days.  About 5-6 days after receiving the vaccine my husband had tingling and a prickly feeling that ran down from my arms down to my toes but mostly on left on the side. It felt like an electrical simulation this lasted for one night.
Drug ineffective; tested positive; chills; fever; headache; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 2nd of two reports.   A female patient of an unspecified age (30-40 year-old)started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration on 02Dec2020 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient was tested positive to COVID-19 on 24Dec2020 after having chills, fever and a headache. The outcome of the events was unknown. The reporter stated that these were worse than just side effects. The reporter is wondering if the patient can receive the second dose.  Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented 7 days after the 2 dose. This case does not match this requirement,Linked Report(s) : US-PFIZER INC-2020512742 different patient, same drug and event
Extreme fatigue and whole body weakness; Body aches, especially in my back; Body aches, especially in my back; Nausea; Chills; headache; Extreme fatigue and whole body weakness; This is a spontaneous report from a contactable Consumer (Patient). A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 12Feb2021 07:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 21Jan2021 07:00 as single dose for covid-19 immunisation. On 13Feb2021 04:00, The patient experienced body aches, especially in my back, nausea, chills, headache, extreme fatigue and whole body weakness. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
I received a flu shot administered by pharmacy employees at the site of my employer (half the company got one), and had a one day strong flu-like reaction, however that resolved itself as expected and is not the main concern here.  The problem is that I have had persistent soreness and pain in the site of the injection (my shoulder) since the day it was administered. My shoulder has good days and bad days, but the pain has never completely gone away, and at the time of making this report, it's ad bad as it ever has been.  I never had any issues with my shoulder prior to receiving the injection. I have received no treatment yet, but I am going to go to the doctor soon.  It is very clear to me that something bad happened when I got this shot.  I should note that in past years when I got the flu shot the soreness would be gone in a couple days.  Not this time.
Chest pain started on 01/30/2021 around 1pm. At this time the chest pain was constant. The next couple of days the chest pain was only on exertion. The chest pain got better and I only experienced slight SOB of exertion over the next few days. Last night (02/07/2021) I experienced extreme dizziness (when walking and lying down). While laying in bed the room was spinning.
Aches, chills, fever, full body pain, headache, unable to sleep due to shakes & chills. No appetite. Arm is incredibly sore that I am unable to lay on my right side nor pick anything up beyond taking a sip of a drink without it hurting. Getting hot & cold throughout the day. No energy and tired at all times.  My entire body feels sick.
Fever of 101.9; Body aches; Body chills; Moderate Headache; Nausea; Nose bleed; Lethargy; Rapid heart rate; Mild chest pain.
Bell's Palsy and was given antiviral(on this for 10 days)and steroid, Red welt that lasted a week.
SWOLLEN GUMS; BLISTERS; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced swollen gums and blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen gums and blisters was not reported. This report was non-serious.
Patient had excessive bleeding immediately following administration of the immunization. After the bleeding subsided, there was a marble size bump under the skin where the immunization was given. Patient felt fine and had no complaints or concerns when he left the store.
Pt had severe red spots all over her body.  Pt also reported to have blisters and bleeding from these blisters in her mouth.  Pt went to see her doctor on 8-29-16 who diagnosed her as "vasculitis" adverse reaction from the vaccine.  Pt was given Medrol dose pack 4 mg course for 6 days.  Pt's blood was drawn to make sure her platelet was within normal limit.  Pt will monitor herself, if excessive bleeding, she will call her doctor asap.
2 days after getting MMR, pt noticed small bumps on legs, described as "heat bumps" that spread on legs and stomach, 6 days later had some nausea and HA.
CELLULITIS  AT SITE OF INJECTION FEVER MUSCLE ACHES NAUSEA. 02/04/2008 MR received for DOS 11/2-5/2008 with D/C DX: Reaction to Pneumovax in the Left upper extremity with cellulitis and inflammation,  Diabetes mellitus, insulin dependent Type I, Hx of irritable bowel syndrome.  Pt presented to PCP office with fever, a large erythematous region with edema surrounding the L deltoid. Txd with abx and d/cd with improvement
Adverse effects: shivering, migraine headache, tiredness, hives, rash on scrotum, nausea, whole body pain, swollen left arm, neck, throat and face, difficulty breathing, chest pains, inability to do normal activities from being bed bound for 3 days. Treatment: Bed rest for 3 days because all emergency rooms full.
Information has been received from a physician concerning a 31 month old white female, with no known drug allergies, who on 04-FEB-2004 was vaccinated with a subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot# 647242/0895N). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 10-AUG-2005 the patient experienced a new itchy, vesicular rash noted to be small chickenpox on her mid-body with more new lesions on the next day. It was noted that there was no fever and the patient did not seem ill. Medical attention was not sought. Follow-up information from a woman working at a physician's office indicated that on 11-AUG-2005 the patient experienced small vesicles of chickenpox on her skin. It was reported that the patient recovered. Additional information is no expected.
I tire very easily now. I have had multiple sinus issues and ear aches.  My sinuses have been the worst.  I have had shortness of breath when i get tired. I don?t feel myself since the shot.
pt recv vax & approx 14 days p/vax pt exp 2 lesions on leg;
This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included covid, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced feeling hot. On 06-MAR-2021, the subject experienced blister on lip. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced fever. On 08-MAR-2021, the subject experienced stomach ache. On 08-MAR-2021, the subject experienced shingles. On 08-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne. Laboratory data included: Blood test (NR: not provided) Within normal limit (units unspecified), and Disorder thyroid (NR: not provided) Within normal limit (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 07-MAR-2021, stomach ache, and nausea on 09-MAR-2021, and feeling hot, and headache on 08-MAR-2021, was recovering from blister on lip, and had not recovered from blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne, and shingles. This report was non-serious.
Initial unsolicited report received from physician (Practitioner) 17-JUL-2018. This case is linked with case 1-1432083702 (2018SA198300, male patient) (same reporter). This case involves a four-month old female patient who was vaccinated with an expired dose of PENTACEL in left thigh (Batch number: C5400AA, expiration date: 24 June 2018, dose, route of administration was not reported) on 17 July 2018. It was an actual medication error due to expired vaccine used. It was not reported whether any adverse events occurred. 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 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.
battling cold for a few weeks - one month" overall improved. Last OV w/ Dr. on 07/30 had "cold for 3-5 weeks prior to that. One of children received abx. No fever at home. Mild headache yesterday but no neck stiffness. Worsening sore throat. No difficulty breathing/SOB. Ongoing mild dry cough (improved). No tongue swelling or difficulty swallowing. + fatigue. Similar to flu sx. No rash. no myalgias. Felt worse after receiving tetanus shot on 08/15. Reports similar feeling after previous tetanus shot ~10 years prior. In clinic febrile to 101.0, HR 70 BP 118/73. OP notable for posterior erythema but no tonsillar exudate or tongue swelling.
Pt. had an adverse reaction approximately 5-10 minutes after recieving immunization.  Pt. had a hard to describe reaction that resulted in a mixture between syncope/seizure type reaction with some symptoms of both.   Upon further communication it was conveyed to me that the patients ekg was abnormal and they believe he had a undiagnosed cardiac condition that was brought to light from the stress of recieving the vaccine.