chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 27 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three dose of DAPTACEL; (lot numbers reported as C, lot numbers not reported) on 01 July 2008, 22 August 2008, and 15 October 2008, (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 24 April 2012, approximately three and a half years after the last dose. On 24 April 2012, the subject developed a cough and paroxysmal cough on 02 June 2012 without whoop. Laboratory testing included positive PCR on 06 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of BACTRIM, starting on 08 June 2012 for 14 days. The subject was not hospitalized. At the time of final contact of 26 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 55 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 180 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 11 October 2012. These 180 cases represented children who received three 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. Documents held by sender: None.
Upper left back pain; Left arm pain; Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), VACCINATION SITE PAIN (Left arm pain) and BACK PAIN (Upper left back pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced INFLUENZA (Flu symptoms) and VACCINATION SITE PAIN (Left arm pain). On 04-Nov-2021, the patient experienced BACK PAIN (Upper left back pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. At the time of the report, INFLUENZA (Flu symptoms), VACCINATION SITE PAIN (Left arm pain) and BACK PAIN (Upper left back pain) outcome was unknown.            No concomitant medications were reported.
3/6/07 Rt upper arm red, swollen, warm to tender, 3/7/07 RT upper arm red, swollen, warm et tender to touch, 3/8/07 Rt upper arm sl red, sl swollen, sl warm to touch.
Approximately after 20 minutes after vaccine  administration, my  throat felt numb and i could not swallow my saliva, no acute breathing difficulty  , I could not swallow water , I  was very anxious and went back to facility I got vaccine , The attending doctor administered Benadryl I 50 mg IM , and then EPI 0.3 mg . EMT was called , and  ED at Hospital i was attended , and Solumedrol 1.25 mg was administered IV and Pepsid for GERD , i also had,   I was observed for a few HRs and skript for Prednisone and Benadryl was issued.  I was then feeling better,
Vasovagal syncope, painful/inflamed lymph nodes on right side of neck/clavicle
Cold, fever, chills, muscle aches, runny nose, sneezing, tiredness, diarrhea  Occurred 1 day following vaccine  Continued for 2 days
Pt vaccinated with Pneumococcal vaccine, no sign of infection, temp 99.6 at 2PM. temp 101 at 4PM at 2AM upper resp infection symptoms & temp 100.8, chest x-ray on 6MAR shows increaed markings L base compatible w/pneumonia.  Placed on Ceclo.
Flu like symptoms for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 3 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A2(orZ)1A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Jan-2021.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-1 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
he was tested Covid-19 positive; he was tested Covid-19 positive; This is a spontaneous report from a Pfizer sponsored program, reported by contactable consumer (patient self-reported). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date in 2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not provided. It was reported that patient had his first dose of Pfizer Covid-19 vaccine a week from today in 2021 and scheduled to get his second dose next Tuesday (20Apr2021) however he was tested Covid-19 positive in 2021 and wanted to know if he can still get the second dose. Outcome of the events was unknown.  Follow-up actions are needed. Information about lot and batch number has been requested.
Patient received her vaccine and the vaccinator noted the dose did not get administered in the patients arm in was dripping down the patients arm. Pharmacy team on sight and myself made aware of the faulty needle/ syringe and the vaccine was readministered to the patient.
First day, just headache.  Woke up second day with aching in both arms, third day swollen glands in neck, and an itchy rash on several places -- near my waist, on one thigh, on one forearm
This case was reported by a physician via call center representative and described the occurrence of formication in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced formication, reaction gastrointestinal, malaise, fatigue and fever. On an unknown date, the outcome of the formication, reaction gastrointestinal, malaise, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the formication, reaction gastrointestinal, malaise, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: This information was received via chat. The age at vaccination was not reported. The healthcare professional (HCP) stated that, the patient had a full week of adverse reactions to SHINGRIX that included; fatigue, fever, malaise, gastrointestinal reaction, and formication. The HCP stated that, the SHINGRIX was administered at another location and he did not have vaccine information for the reported adverse events. This case is 1 of the 2 cases reported by the same reporter.
2 episodes of extreme dizziness/vertigo within 24 hrs after my first shot.  Also chills & fatigue.
FEELING A LITTLE BLAH; FEVER; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling a little blah, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and feeling a little blah was not reported. This report was non-serious.
severe migraine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 07Apr2021 at single dose for COVID-19 immunization. Medical history included migraine cycles a couple times a year and usually take oral prednisone. Concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on 10Mar2021 for COVID-19 immunization. The patient called to ask if it is okay for her to take Prednisone as taperingdose prescribed by her Doctor due to severe migraine (Apr2021) after getting her second dose of the vaccine since her Doctor is not also sure if it is okay to take the said medication after her second dose of the vaccine. The outcome of the event was unknown. Serious was No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Migraines Muscle Soreness Fever Chills Fatigue Nausea Pain at Injection Site Right Arm Pain "COVID Arm"
Case reported she had feeling of feeling" hot throughout body" about 20 minutes after administration of vaccine.  Reportedly "just don't feel right".  Reportedly never experienced anything like it before.  Also reported some dizziness.  "Feels like I should be sweating, but I'm not".  Observed and given water initial.  BP 120/90 .pulse 88.  No shortness of breath,  Administered  50 mg of benadryl approx 10 10 am since "burning feeling was not resolving"  Continued to be observed x 40 minContacted emergency contact to provide transportation .  She declined use of epi-pen.  She contacted doctors office during observation period to notify him of reaction.  I had instructed her to take benadryl again at 4pm if any symptoms return and to call 911 if symptoms worsened.  Her physican contacted her at home and provided the same instructions.l  Contacted case again today.  Symptoms resolved after napping yesterday.  She returned to work today
Near fainting episode after receiving vaccine. Red patches noted on hands, forearms, chest and back with pt. c/o itching approx. 20 min. after vaccine.
On day 9 or 10, I developed a reddened area at injection site about the size of a quarter.  It has since grown to about the size of a baseball.  It is raised, red and warm to touch.  And it itches like crazy!
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 17Oct2021 at 15:00 as dose 1, single (Lot number: PF2590) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Kidney stone" (unspecified if ongoing); "Seborrheic dermatitis" (unspecified if ongoing); "Benign heart murmur" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin base, reaction(s): "known allergies: Erythromycin base"; Tamsulosin, reaction(s): "known allergies: Tamsulosin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (12May2022) Negative, notes: First negative antigen test (Cue) after starting paxlovid; (18May2022) Negative, notes: Still testing negative with antigen test (Cue) at this point; (19May2022) Positive, notes: Started testing positive again (antigen, Cue). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details Product Covid-19 treatment Brand Paxlovid Treatment start date 09May2022 Treatment stop date 14May2022, Lot Number: GA8200, Indication Treatment of Covid-19 About 12 hours after starting Paxlovid (9May2022 7:38 PM), noticed bad taste in mouth (metallic) even toothpaste tasted awful. This was persistent while on Paxlovid. 09May2022 7:38 PM Started (antigen testing positive, Cue). 12May2022 7:47 AM - First negative antigen test (Cue) after starting Paxlovid 18May2022 8:48 AM - Still testing negative with antigen test (Cue) at this point. 19May2022 7:53 AM - Started testing positive again (antigen, Cue).19May2022 9:30 AM - Met with PCP to discuss rebound: my symptoms, very small headache, no fever, postnasal drip / nasal congestion, fatigue
redness, warmth to touch, mild itchiness, tender to palpation and lump about 4 cm diameter at injection site.  No systemic symptoms, all local.
flu-like symptoms; a fever of at least 102.3; dizziness; chills; sweating; full body aches; extreme fatigue; headache; The milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on  a typical day; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 at 16:45 as DOSE 2 SINGLE (Age at vaccination: 31-year-old) for covid-19 immunization at Hospital. Medical history included I gave birth to my first child on 12Mar2020. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) taken for an unspecified indication. The patient had no covid prior vaccination and no covid tested post vaccination. The patient did not take any other vaccines within 4 weeks. The patient had no known allergies. Historical Vaccine received as bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 at 06:45 as DOSE 1, SINGLE for covid-19 immunisation at Hospital and experienced flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. On 05Mar2021 at 06:00 The patient experienced flu-like symptoms, fever, dizziness, chills, sweating, full body aches, exhaustion, headache, and the milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on a typical day. It was reported that for second shot, the patient had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. Patient started having symptoms approximately 13 hours after her shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When the patient was unable to breastfeed, the patient pumped and have frozen milk from before, during and after my second dose. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.3 on 05Mar2021. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Maintained heart rate of 140-150 BPM the day after vaccination for approximately 12 hours; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included obstructive sleep apnea. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 07:00, the day after vaccination, the patient's heart rate was maintained at 140-150 beats per minute (BPM) for approximately 12 hours. On the same day, the patient underwent heart rate measurement and the result was 140-150 beats per minute. The event did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event maintained heart rate of 140-150 BPM the day after vaccination for approximately 12 hours was resolved on 02Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
woke around 7:00 a.m. with low grade fever, then around 1:00 p.m. fever up to 104 deg. The site around the injection site were red and hard mom treated sx with tylenol. Fever came down. Redness and hardness went away after almost a week.
He stated having shaking real bad and they have gotten worse. If he is not holding onto anything he will fall. He went to the ER and they determined it was not a seizure.
This spontaneous report as received from an unknown age female consumer refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced pain and swelling at the injection site. The outcome of the events was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
child received an extra dose of Hib; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old female patient who experienced child received an extra dose of hib, while she received vaccines ROTAVIRUS VACCINE, PREVNAR 13 and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jun-2019, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UI954AA via intramuscular route in the left thigh. On an unknown date, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a  dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported.  It was of actual medication error due to  extra dose administered.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Patient received vaccination and was observed for 15 minutes and was released after 15 minutes with no complications. Patient went home about 2 hours later noticed pain around injection site and swelling. (16:30) By 1930 patient states "she was in horrible pain and wanted to cry and couldn't remove her clothing for bed." She was unable to sleep that evening due to being in pain (continued)
took first dose of Moderna vaccine after 2 shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer). On 08-Apr-2021, EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114898 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information  received on  09 Jun 2021 contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114898:dose 2
Headache Muscle Aches Joint Pain Extreme Fatigue Shoulder & arm so sore could not lift arm up
Moderna monovalent peds 6-11 administered in error.  Should have received Moderna Bivalent booster.  Manufacturer box is marked as booster.  Attempt to contact patient, contact number and emergency contact are not good numbers.  Person answered stated wrong number.
one week post vaccine #2, employee states hives over various areas of body including: belly, thigh, groin, armpit, right arm.  Employee has taken OTC Benadryl. 25mg 3 times per day.
It was reported that a female patient received a Fluzone SV'00-'01 vaccination on 6 Nov 2000. Approximately 5 hours after vaccination the patient developed ulcers in her mouth and swelling of her tongue, no respiratory distress and pain in her jaw. Further information is requested. From additional correspondence received on 8 Mar 2001, it was reported that the pt experienced pain when attempting to open her mouth. The pt reportedly recovered from this experience with no sequelae. Add. pt, lab data and responsible physician information were also provided.
Hot flashes.  Currently on Tamoxifen (previously diagnosed with ER/PR+ breast cancer) and have not had hot flashes or night sweats for 2 years.  After the vaccine, started getting them again. Increased Estradiol.  Value for the last measurement (31Jan2020) prior to the vaccination was <11.8.  After having the hot flashes for a while, had the value tested and now the value is 610.4.
While sitting in observation following vaccine administration pt told observation nurse that she felt "warm" and "faint". She stated she felt well enough to walk so she was brought to EMS guided by RN and care was transferred to EMTs. With EMTs she was placed in wheelchair and wheeled outside for fresh air. With EMTs she reportedly lost consciousness for ~30 seconds. When she regained consciousness vitals taken by EMTs were reportedly BP 150/80, HR 68, and O2 98%. She reported chief complaints at this time to be fatigue, nausea, and chest pain. She was then transferred to ED via ambulance with onsite EMS for further evaluation.