chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a little soreness; slight headache over the past hour; developed pretty bad congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 17May2021 09:00 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bronchitis" (unspecified if ongoing), notes: since usually he gets bronchitis every year, but he has not had it this year. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 17May2021, outcome "unknown", described as "felt a little soreness"; HEADACHE (non-serious) with onset 17May2021, outcome "not recovered", described as "slight headache over the past hour"; NASAL CONGESTION (non-serious) with onset 17May2021, outcome "unknown", described as "developed pretty bad congestion".  Additional Information: Patient would like to know if it was safe to take Mucinex after the covid vaccine. Patient got his 1st dose of Pfizer this morning about 9:00. Patient says he felt a little soreness and a slight headache over the past hour, patient developed pretty bad congestion. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got flu shot at 1:15 PM, 2 hrs later I noticed itchy eyes, scratchy throat and tiredness. By 5 PM was wheezy, watery, mattered eyes. 6 PM got severe chills, then got hot-sweaty approx 8 PM had trouble breathing - tightness in throat, started passing out. Went to E.R. given nebulizer, X-rays, CT scan, blood work, EKG, etc.
Next day after vaccinated, patient has an itchy rash in the antecubital space of the left arm.   It is similar to the itchy rash she also experienced with her second COVID shot (Moderna).  Using  Benedryl cream recommended by the Pharmacist at pharmacy for the itch.
heat rash; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heat rash. heat rash a week on one side later following sun exposure. Sitting in the car with capirs on, has since resolved. Related it to a heat rash following use of tetracycline 15 years ago. The outcome of the events was recovered on an unspecified date.  PQC Details:  Request Name: REQ-275831 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller was on hold trying to reach. Reports first dose 21Apr2021, heat rash a week on one side later following sun exposure. Sitting in the car with capirs on, has since resolved. Related it to a heat rash following use of tetracycline 15 years ago. Granddaughter hung up phone. Callback @ 1541. Response: Spoke from attached.  Warm transfer to Reference #za2wis1t.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Local reaction. 40mm X 26mm area of erythema and itching at site. No systemic symptoms. Similar to previous reaction to MMR on 6/2/08.
Cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Cough".  Additional information: Caller with held would like to reschedule his appointment for the booster shot for the Pfizer covid-19 vaccine But She mentioned that She developed a little cough and decided that She did not want to come for the appointment.  Follow-up (28Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient stated she had received the Janssen vaccine in April and had an anaphylactic reaction that she was taken to the hospital for and given epinephrine. She spoke with her MD who recommended she get a different brand for her second dose. She chose Pfizer. She had no other allergies that she shared with us. About 2-3 minutes after receiving the Pfizer dose she felt her throat was scratchy and her tongue felt thick, I gave her 50 mg of Benadryl po. At about 4 minutes after she said she definitely felt like she did after the J&J vaccine. At this point EMS was called, her BP and pulse were WNL, I gave her epi via Epi-pen in her right thigh. She had no difficulty breathing but felt like her chest was a bit tight. EMS arrived about 10 minutes after her dose. She was talking, BP and pulse remained stable, O2 sat was 100% per EMS oximeter. She was transported to our local ER. I spoke with her today and she was feeling well except for a sore arm and a bit achy overall. She reported the ER did not repeat epi but gave her Solumedrol and a nebulizer treatment.
Fell down, Extreme disorientation, shaking arms and hands, elevated blood sugar, elevated blood pressure and elevated heartrate.
Fingers turned blue on her ring finger and pinky of right hand, both hands went numb and cold, about 5 instances of what her doctor called raynauds syndrome. Pt hasnt seen her DR in person but did send her DR photos
Itchy rash near the injection site appeared 2/21/21. 2 1/2 inches long, 2 inches wide.  There is still a faint pink border as to where the edges of the bandaid were (noted on the V-safe site of  redness where bandaid was - no pain or itchiness symptoms at that time).  The upper part of the rash touches the lower part of the pink bandaid outline.   Bandaid outline still has no pain or itchiness.   This symptom did not occur until after all the V-safe checking were complete.  I have taken a Claritin and  put anti itch cream on the site.  At this point I do not have enough concern to notify a doctor.  I will contact Teledoc if the rash spreads further or adversely changes in any other ways.
was administered Shingrix instead of HEB; was administered Shingrix instead of HEB; has been fussy; experiencing sleep regression; This case was reported by a consumer via call center representative and described the occurrence of irritability in a 2-month-old male patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 13th July 2020, the patient received Shingrix .5 ml. On 13th July 2020, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. In July 2020, the patient experienced irritability and difficulty sleeping. On an unknown date, the outcome of the irritability was recovering/resolving and the outcome of the difficulty sleeping, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the irritability and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: A two month old baby was administered Shingrix in thigh instead of Heb vaccine at his two month visit which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was in leap two and had been fussy and experiencing sleep regression where he would not let his mother put him down to sleep. The reporter stated that she had to hold him which was not like him.  No other events were reported. The reporter consented to follow up.
12OCT95 10AM pt had vax & mom states 7PM pt spiked a fever had febrile sz taken to ER-no other cause for fever found;
Information has been received from a pharmacist concerning a 72 year old female with blood pressure high, who on 13-MAR-2008 was vaccinated with ZOSTER (Merck).  Concomitant therapy included unspecified blood pressure medication.  About a month after vaccination, in April 2008, the patient developed welt like marks on the same arm as the injection site.  The patient sought medical attention at an office visit.
Pt reported on 8/20/2020 as his upper arm and lower arm was swollen & warm on 8/18/20. On 8/20/20 upper arm is better, but lower arm is still little swollen, getting better. slowly recovering.
Received PREVNAR 13 and FLUZONE HD on 9/16/15 in the afternoon. The next morning around 7 am, pt woke up with chills, body shaking all over. Pt stated she got a blanket and wrapped it around herself. She states her body shook for about 3 hours-she sat in a chair, no treatment, shaking subsided after about 3 hours and pt then felt a little "woozie" but then felt a little better. Pt stated she also had no appetite all day.
Hepatitis A vaccine #1 given at 230 pm on 2/14/06. Pt developed fever 101 degrees and diffuse fine somletineform rash at 9 am the following day 2/15/06. Pt examined in office with T 102 with above rash noted and fresh blood in nostril. Rash present in groin, on face and on extremities, lasted 3 days. Fever lasted 5 days.
Patient had a very red, blotchy, scab like rash all over his left chest and going to his shoulder. This was not evident on his arm.
After first dose the next evening muscle and joint pain in left wrist, left lower arm and left hand. Swelling in left wrist and hand difficult to close hand. Stinging pain in left wrist, left lower arm and left wrist. Stinging pain still comes and goes in left lower arm, wrist and hand. Pain and swelling has improved. Second dose in right arm was normal with no adverse reactions.
Large round welp 4-5 inches wide. Not raised anymore by day 3 but still the same size. Not painful or itching. Hot to the touch.
anaphylactic reaction; This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix Trivalent 2012-2013 season) (batch number AFLUA736AA, expiry date 30th June 2013) for prophylaxis.   On an unknown date, the patient received Fluarix Trivalent 2012-2013 season. On an unknown date, unknown after receiving Fluarix Trivalent 2012-2013 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Trivalent 2012-2013 season.  Additional details were reported as follows: This case was reported by pharmacy student. The age at vaccination was not reported. The patient had a severe anaphylactic reaction to Fluarix 2012-2013 vaccine.  The reporter was unsure if it had already been reported back when it happened and did not have patient initials.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive for Covid about one week after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received no other medication in 2 weeks. The patient received anti-viral Paxlovid (lot number:1918528A) from 27Jul2022 to 31Jul2022 for Covid 19 Treatment. No known allergies were reported. The other medical history was reported as None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 27-JUL-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The report stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Pfizer vaccine was administered outside of the clinic - reported by patient   ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 6/30/2021 ANEMIA DUE TO CKD  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/3/2021 ANEMIA DUE TO CKD  ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 6/30/2021 ANEMIA DUE TO CKD  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/3/2021 ANEMIA DUE TO CKD         ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 6/30/2021 ESRD ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS    STROKE, CARE OR CASE MANAGEMENT  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/3/2021 ESRD ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS    STROKE, CARE OR CASE MANAGEMENT  ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 6/30/2021 ANEMIA DUE TO CKD  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/3/2021 ANEMIA DUE TO CKD  ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 6/30/2021 DM 2 W CKD, ESRD ON DIALYSIS W HTN  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/3/2021 DM 2 W CKD, ESRD ON DIALYSIS W HTN
Pt. received a flu vaccine on 10/11/2018 at the school. Pt. came into ED with reddening of the upper right arm; same location that flu vaccination was given. Reddening of arm was from right shoulder to elbow of pt.
Dizziness (2:10pm),  shortness of breath (2:15pm), itching (2:30pm) Resolved with intramuscular diphenhydramine (50 mg) given at 2:50pm
1/25/21 1100: received vaccine 1500: head/nasal congestion started 1900: headache started and I became more lethargic 2000: severe headache with pressure behind the eyes  2100: body aches started specifically in the neck and then professed to lower back and Tylenol was taken. Afebrile at the time.  2300: temperature of 100.2 1/26/21 0300: awoke with severe rigors, chills, soaking wet bed sheets and massive headache. Nauseous, very lethargic and 1 mild episode of diarrhea. Temperature of 100.6. Took more Tylenol.  Insomnia started and was sleeping at 20min intervals.  0500: awoke again with chills and extreme fatigue and moderate body aches. No more nausea or diarrhea. Called in sick to work.  0700: fever of 101.1. Took more Tylenol. Finally got some sleep.  0900: fatigue and body pain still 1000: fever of 102.5 and took more Tylenol.  1200: fatigue and still will headache despite fluid hydration all night and morning.  1400: temperature of 100. Fatigue improving but still in bed since 8pm the night prior.  1600: fever of 101 and took more Tylenol   Most Symptoms resolve after 36hrs and went to work the following day with fatigue, neck pain and headache.
Redness and pain/warm to touch. 9 x 10 cm induration.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 05-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
FIRST DOSE ...Had extreme energy surge (rapid heart etc) had insomnia for 2 days.  In the 2 days following the shot I slept for a total of 1/2 hour or so.  I was exhausted prior to shot so sleep should not have been as issue. I also had lots of confusion.
Incessant crying 3 1/2 hours after immunization. Lasted for at least 2 hours. Given TYLENOL.
I contracted COVID-19 on 06/06/2022 with symptoms of cough, fatigue, congestion, shortness of breath, one bout of vomiting, and headache. My doctor prescribed molnupiravir 200mg 4 capsules 2 times daily for 5 days, doxycycline 100mg 2 times daily for 10 days, and take MUCINEX and COLD-EEZE on 06/07/2022. After 24 hours of beginning the antivirals my symptoms began to improve, and I am no longer having a headache.
Red bump at the injection site; Shooting pain in the jaw; Shooting pain on the neck that extended to the left side of her jaws up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Shooting pain in the jaw), NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down) and VACCINATION SITE ERYTHEMA (Red bump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Macrobid allergy).   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Feb-2021, the patient experienced PAIN IN JAW (Shooting pain in the jaw) and NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red bump at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PAIN IN JAW (Shooting pain in the jaw) and NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red bump at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other (Inconclusive) Went up and down for 36 hours and reached 99.87F.         Concomitant medication included Elquiis
Muscle ache; sore throat; "heart skipping" (patient has experienced this before vaccine).
Felt slightly nauseous in stomach, slight headache.  Limited diet to foods that seemed to settle stomach - toast, etc.  Lasted all day..
Body aches like with the flu; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot number: unknown) single dose via unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history and concomitant medications were unknown. On an unknown date, the patient experienced  body aches like with the flu for three days. Treatment for the event was unknown. The clinical outcome of body aches like with the flu was recovered on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Chills, some fatigue and body aches.  Left arm sore, red, and hot to touch
pt had vaccines on 3/18 and on 3/22 developed rash on body, arms and legs and buttox, spares abdomen and back and face. mom putting hydrocortisone on area with some relief. rash improved at visit on 3/24, but still with some present. treated with antihistamine and exam done. called mom 3/26/21 to check on child, voicemail left. no swelling of lips, tongue or joints. no fever. acting well and eating well. sleeping well.
hot ascending feeling over entire body; dizzy during day; room would spin apprehension; lost 6 lbs;
This is a breakthrough case. I got COVID-19. I had a scratchy throat, cough, and sore throat from coughing. I seen the doctor and she prescribed me a pill. These symptoms lasted for 5 days.
Adverse event: Vaccine was administered 16 days after beyond use date and is less effective. Treatment: Pt returning to our office for additional vaccine based on Pfizer recommendations.
This spontaneous report as received from a nurse refers to a two unspecified patients of unknown age and gender. On 25-AUG-2014 the patients were vaccinated with an improperly stored dose of VARIVAX (merck) (strength, route, lot number and expiration date not reported). No adverse events were reported. Additional information has been requested.
09:32--pt received dose 1 moderna vaccine  09:37-pt c/o generalized itching/mild redness on forearms and abdominal area pt took 25mg oral benadryl of own supply and 25mg oral benadryl pharmacy supply + 20mg oral pepcid 10:15--pt reports resolution of symptoms and verbalizes understanding of premedications for next vaccine and will report to ER should symptoms change
Rash Erythematous; Rash Vesicular Information has been received from a physician concerning a 12 month old female with no known allergies or medical conditions who on 04-MAY-2004 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 648047-1346N). Concomitant therapy included a third dose IM in the right arm with HIB conj-hepatitis B vaccine (MSD) (lot#647167/1113N). There was no illness at the time of vaccination. On 06-JUN-2005 the patient experienced an erythematous vesicular rash and no other symptoms. The rash resolved with supportive care. No lab tests were done.  The patient's brother (WAES 0509USA03955) had similar symptoms after vaccination with varicella virus vaccine live (Oka/Merck). Additional information is not expected.
Redness at the injection site; slight itching; A spontaneous report was received from a 83-years-old  female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight itching and redness at the injection site.  The patient's medical history was not provided. Concomitant medications reported were losartin, eliquis for drug use for unknown indication.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event slight itching.  On 5 Feb 2021, the patient experienced the event redness at the injection site.  Treatment details included Tylenol for itching.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, slight itching  was unknown and redness at the injection site was considered recovering.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.