chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light flu-like symptoms; Achy joints; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills) outcome was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-392085, MOD-2021-392056 (Patient Link).
Mom described a "knot" under the skin where shot was given almost 2 wks after shot was given. No "redness" or "red streaks" from site reported. "Feels like scar-tissue" No infection reported.
Started with sinus pressure, pain, sore throat, and cough. Fatigue set in after a couple of days after and felt the need to see the Doc. Was given a COVID-19 Test which came back positive. Was advised liquids/bedrest etc. Came back on 3/27 for IV infusion.
1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 10-May-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 10-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.
PROBLEM:  Rash, right neck and shoulder area. SUBJECTIVE:  I meet acutely with this 67-year-old man, rash starting about 5 days ago now, no prior history, did get COVID shot in the last 2 weeks, no history of shingles.  Applying topical steroids with some good relief.  His only regular medication is pravastatin and aspirin.  No headaches or visual changes.  No F/C. SKIN EXAM:  There is a vesicular rash, patches, right neck area, extending into right trapezial and upper back area, dry, no spreading redness.  Right ear looks fine. ASSESSMENT AND PLAN:  This is almost certainly shingles, now 4 to 5 days old, doubt antivirals will help, looks pretty dry, perhaps it was triggered by vaccination.
Generalized muscle aches; lethargy; This is a spontaneous report from a contactable physician. A 62-year-old male patient received first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the left arm, on 18Dec2020 12:45 at a SINGLE DOSE for covid-19 immunization.  Medical history included hypertension (HTN). 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 hasn't been tested for COVID-19. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCT), amlodipine and aripiprazole (ABILIFY).  On 19Dec2020, the patient experienced generalized muscle aches and lethargy. The outcome of events was not recovered.  Therapeutic measures were taken as a result of events included OTC motrin and Tylenol.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
When the patient left the immunization room she stated she wasn't feeling well and felt dizzy.  As an employee was helping her get to a chair, the patient fainted.  The employee helped her to the floor. She awoke almost immediately.  Her husband was called to come pick her up.  She was fine by the time he got there.
MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION. EMS ON SITE. PATIENT TRANSPORTED TO ER. GIVEN BENADRYL AND SOLU-MEDROL ON SITE.
Patient reports feeling lightheaded, flushed, and nauseous just prior to syncopal episode.
Severe pain in right side then the break out occurred with welts and blisters on that side, the break out occurred 1 1/2 days after the severe pain.
Patient experienced a lot of chills, muscle pain, and weakness overnight after the vaccination. Was very tired the next day and was still experiencing a lot of muscle weakness throughout the day.  Patient did not report fever and is slowly feeling better as the day progressed (9/11/18).
Patient was administered the COVID vaccine and felt fine.  He relocated to our pharmacy waiting area for observation.  Once there he started to read the provided material (EUA, V-Safe) and started to feel anxious.  He said the next thing he knew he was sweating and had tunnel vision.  He wasn't 100% sure he passed out.  A fellow associate helped him to the ground and elevated his feet.  We got ice for behind his neck, and a cold cloth for his forehead.  We took his blood pressure and it started to come back up.  He waited for about 30 minutes before leaving.  His color had returned and he stated he felt fine.
Symptoms started after 15 minute observation - Urticaria.  About 1-1.5 hours after injection. Injection site reaction.  Took benadryl for 2 days - itching and hives.  Rash lasted about 3 days.  on 5/11 - injection site rash gradually grew in size.  Became warm and tender to touch.  No medications since 5/6/21. delayed swelling, redness, itching, tenderness over L. arm  Checked for lyme. Do not see that lab work was every completed. Got second vaccine no issues.
Diaphoretic; Nauseated; Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold). At the time of the report, HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Case is invalid as there is no patient identifier reported
On 29Jul2019, the patient received second dose / On 17Jul2020, the patient was diagnosed with a case of the shingles; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2020, 470 days after receiving Shingrix and 354 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in the left deltoid and second dose of Shingrix in the right deltoid. On17th July 2020, the patient was diagnosed with a shingles, unknown severity and unknown location of the shingles lesions.  The patient was prescribed anti viral for treatment and started treatment on 18th July 2020. The shingles was ongoing at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020087418:same reporter US-GLAXOSMITHKLINE-US2018126864:same reporter
Stinging at time of injection and immediate itching after withdrawal of needle.  This vaccination requires an IM injection and she gave it to me subcutaneously.  By the time I got home, I already had hives, my arm was hot and swollen, and I was in pain. By that evening, I had a headache and was light headed.  The following morning I had trouble standing up because my leg muscles were so weak. My husband had to help me up and I spent most of the day in bed after that.  The size of the hive or whelp (whatever you want to call it) had grown tremendously. The red, hot, hard bump wrapped around the entire back side of my arm.  Not the entire upper arm but the entire area from the injection site.  From Tuesday until Friday my heart averaged between 104 and 108, and I had difficulty breathing.   It's almost 11 pm Friday evening and my hr has dropped down to 88 and am breathing better.
L LEG 20MM LUMP AND REDNESS AT SITE OF VARICELLA VACCINE.
mom states pt devel swelling @ site of inject the size of a grapefruit on 21JUL93; taken to ER; seen by another MD stated there is no problem;
This spontaneous report was received from healthcare worker and refers to a 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 05-DEC-2018, the patient was vaccinated with ROTATEQ orally  (dose, lot number, expiration date were not provided) for prophylaxis. At that time, the patient was 4 months old and did not receive any prior doses (inappropriate schedule of product administration). No known adverse effects.
told mom p/vax that head was itchy, hives found on inspection;c/o rt sided pain 0-10=5;c/o sore throat-saw MD prescribed DPH & did CBC & throat cult states mom;
menstrual changes - onset of night sweats, extremely heavy cycles, irregular spotting leading up to my period, longer cycles, trouble sleeping, increased irritability
INJECTION SITE REACTION; FEVER; INJECTION SITE PAIN; INJECTION SITE SWELLING; HEADACHE; FATIGUE; MYALGIA; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced injection site reaction. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site pain. On 03-APR-2021, the subject experienced injection site swelling. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced myalgia. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site reaction, injection site pain, injection site swelling, headache, fatigue, myalgia, nausea and fever was not reported. This report was non-serious.
BECAME EXTREMELY SHAKY; LOWER BACK MUSCLE PAIN; WAS DISTRESSED; HAD CHILLS; HIP PAIN; FEVER; LITTLE TIRED; VERY COLD; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in afternoon for prophylactic vaccination in left arm. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced little tired. On 27-MAR-2021, the subject experienced very cold. On 27-MAR-2021 01:15, the subject experienced became extremely shaky. On 27-MAR-2021 01:15, the subject experienced lower back muscle pain. On 27-MAR-2021 01:15, the subject experienced was distressed. On 27-MAR-2021 01:15, the subject experienced had chills. On 27-MAR-2021 01:15, the subject experienced hip pain. On 27-MAR-2021 01:15, the subject experienced fever. On 27-MAR-2021 04:30, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from became extremely shaky, lower back muscle pain, was distressed, had chills, hip pain, and fever on 27-MAR-2021, had not recovered from little tired, and the outcome of very cold was not reported. This report was non-serious.
In the morning I have a lot of cramps in my legs and the pain is mostly in my right leg. Second week 08/09/2021 bleeding in the urine with clots. The week of 08/23/2021 I had a manifestation in the eye, with bruises and broken capillaries in the LF eye.
Fever (not measured), diarrhea for 2 days, one episode of vomiting and screaming episode for more than 3 hrs following DTP/OPV immunization.
Symptoms started about 8 hours after shot. Very achy all over, chills, no appetite, and slept all day. All symptoms went away about 36 hours later.
The site where the vaccine was administered (left deltoid muscle) had a large bruise for several weeks and now there is a visible indentation in my arm the size of quarter.  There is no muscle or tissue in the spot where the bruise was. If you run your hand over my shoulder you can feel a "hole". The bruise from the vaccine never healed it turned from a bruise into this indentation.
PATIENT WAS ADMINISTERED 0.3ML OF UNDILUTED PFIZER VACCINE. PT WAS OFFERED AN MD EVALUATING TO INCLUDE AN EKG AND TROPONIN LEVEL. PT COMPLAINED OF FATIGUE, HEADACHE, MUSCLE ACHES, SHE STATED SHE WAS IMPROVING.
Bruising, swelling, redness, warm to touch all at site of injection and approximately 5-6" below injection site on arm as well
This is one case out of a cumulative total of 173 cases solicited from the database during the surveillance period from 01 January 2010 to 15 November 2012. These 173 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 November 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3834AA received on 17 August 2011, lot number C4058AA received on 11 October 2011 and lot number C4083AA received on 13 December 2011 (route and sites of administration not reported). The subject developed cold-like symptoms on 01 October 2012, approximately 10 months after the last dose. On 08 October 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Red bumpy rash on large part of upper arm and very itchy (larger rash than we usually see in pts). Pt thinks it was flu shot but by records probably PREVNAR.
Patient did report anxiety with shots in the par, wanted MMR anyway. Immediately after injection was given she c/o ringing in her ears, lightheaded and blurry vision. She was then sweaty, cool, abdominal cramps, then diarrhea. Patient unable to sit still throughout, skin pale, warm, dry. TC to DR with update observe for 30 mins with return TC to DR to report no difficulty with breathing ore swallowing, patient feeling OK. Mother and father have calmed her down. Patient came into our office with her step father, she was crying. Stated she things she is having a reaction to MMR vaccine. Very anxious C/o of weakness, cramps, however no SE at this time. Pt denied any stiffness, rash and no swelling of glands. She continues to cry. Step father and pt stated that she dose have anxiety and panic attacks. Was referred to her DR and an appointment was made for this afternoon. 5/11/06 TC from her DR she never showed for her appointment.
tested positive a week after receiving first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on an unspecified date in Apr2021 at singled dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that patient received 1st Pfizer dosage 3 weeks ago, tested positive a week after receiving first dose and was scheduled to receive 2nd dose on 04May2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sore arm, headache, body ache, naseau, diarrhea, chills, congestion
Approximately 8 hours, post vax 2nd Anthrax, I started feeling muscle achiness, upon going to bed I had chills and fever, off and on, all night. Went to work the next day and still had muscle stiffness, minor headache with neck muscle achiness. 48 hours, later, symptoms were gone.
15 minutes after vaccine patient had light headedness, body chills and patient said she had a "rush of blood feeling in her body".   Vital signs remained stable and patient observed x 90 mins.
pt recv vax 5SEP96 & exp severe h/a & nausea x 2 days;
This spontaneous report as received from a physician refers to a 65 year old female patient with no pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 0.5 ml intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain (unspecified) and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient was seen in unspecified emergency departments but was not admitted to the hospital. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics in the ER, maybe received oral cephalexin or vancomycin IV. The outcome of events was reported as recovered. The relatedness between vaccination with PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (related to MARRS # 1401USA003077, related to MARRS # 1401USA003078). Additional information has been requested.
Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, body aches and chills noted. Symptoms persisted for 16 hours without intervention of medication. After 16 hours, symptoms were alleviated with 2 doses of 1000mg acetaminophen taken 6 hours apart. 1st dose at 11am on 1/26/21 and second dose at 5pm on 1/26/21
Pt walked back into pharmacy following day after the shot administered (11: 00 AM on 1/6/15). Left arm was noticeably red, elevated hive, warm to touch. Recommended BENADRYL and to see MD. Contacted physician left message.
Vaccine administered at 11:20. At 12:15 patient called and felt chest tightening. Could not stop sneezing, tongue tingling.
First 4 days after vaccine  my arm was sore at place of injection. Took Advil a few times. Evening of 5th day, Aches, chills, weak, 100* fever lasted 4 days. Took Advil, rested.
Staring spells with following focal epilepsy, SCN8A (the cute syndrome) Gene Mutation. Taking KEPPRA (4.6 ml per day) and Phenobarbital (10 ml per day).
Flu like symptoms; arm pain; achy; vomiting; diarrhea; Fatigue; inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea, fatigue and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, pain, vomiting, diarrhea and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. After vaccination with dose of Shingrix, the patient experineced flu like symptoms consisting of fatigue, aching, vomiting, diarrhea and arm pain. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient consented to follow up.