chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Information has been received from an RN concerning a 65 year old female who was vaccinated at another physicians practice with the 1st dose of pneumococcal vaccine 23 polyvalent at the age of 52 and her 2nd dose at the age of 60. On 10/29/01, she was vaccinated with a 3rd dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). On 10/29/01, about 4 hours, post vax, the pt came back to the office with pain in her arm, neck, back and under her breast. She had chills but no fever. She was also vomiting. The injection site was tender to touch. Subsequently, the pt was hospitalized. IV fluids and diphenhydramine hydrochloride (Benadryl) were started. She was also started on therapy with promethazine hydrochloride (Phenergan) for the vomiting. Additional information has been requested. F/U states: The pt was treated with Benadryl, IM, in the physician's office and was kept in the office for observation. The pt still complained of pain so she went to the hospital and was admitted to the telemetry unit where she was treated with IV fluids, diphenhydramine HCI q6 hours and meperidine hydrochloride (Demerol) for pain. She was also started on therapy with Phenergan for the vomiting. The pt was discharged from the hospital on 10/30/01. The discharge dx was intractable pain. The pt was seen in the physician's office on 11/12/01 and was currently receiving physical therapy for her pain. No further information is expected. The pt had no adverse reaction after receiving the 1st and 2nd doses.
Chills; Nausea; Headache; Fever 101.4; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101.4 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter
pt recvd vax & 11AM began to break out in hives 9PM same day; never had hives a/ felt itchy all noc not allergic to any other substance; did not seek med care;
On Sat when child woke, he was running a fever of 101.6.  Mother states there are red dots on his leg especially around the Prevnar 13 site.  Fever lasted throughout the weekend and into 10/21/2019.  Highest fever was 101.6.  Lowest was 101.4.  Tylenol did not break the fever. Mother states child very fussy and did not want to be alone in crib or in pumpkin seat. Mother took child to Pediatrician. Pediatrician stated she did not know what red dots were on Rt thigh. Mother was given instructions that if they got worse or if mother noticed any change (more red, more of them) she was to return. Pediatrician told mother she might expect at least another 2 days of fever based on immu given.  As of 1:00pm 10/22/2019, fever has broke and child not as fussy. Still has red rash/dots on Rt leg.
Pt recvd 3 doses of Engerix-B & found to be a non-responder;
FEVER; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient experienced allergy when treated with benzylpenicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 16:30 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced muscle aches. On 17-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, and headache. This report was non-serious.
Uncontrollable crying for 4 hours, fever 101, vomiting 3 days after administration reported per Dr. at clinic.
Narrative: As per ED note, 6/17/2021: 48 year old MALE presents with: Chief complaint of shortness of breath and persistent cough. Patient states that he took his second dose of Pfizer vaccine yesterday and late afternoon and then when he got home he started experiencing shortness of breath and persistent cough he states that he feels that he has a feeling of something inside his throat. Patient states that he has been having trouble swallowing but he has never attempted to eat anything since yesterday because of cough and discomfort in his throat. Patient denies any history of allergies he denies having any allergic reaction with his first dose of the vaccine. Patient does admit that he has G6PD deficiency. HEENT he denies any nausea or vomiting or any diarrhea or chest pain. MEDICAL DECISION MAKING: We'll order CBC CMP as well as chest x-ray will also give 125 mg of Solu-Medrol and 25 mg of Benadryl IV. We'll consult ENT to make sure there is no swelling or edema in the posterior oropharynx. Patient has been evaluated very ENT and there are no evidence of obstruction or edema in the posterior oropharynx Lab(s) interpretation: WBC 16.12, CMP wnl, rest of WBC wnl EKG: NSR with HR 96 BPM and no acute ST or T wave changes Meds: IV Solu-Medrol 125 mg, IV Benadryl 25 mg, Lasix 20 mg IV Radiology: XR Chest: Subtle findings suggesting central pulmonary vascular congestion and nonspecific hazy infrahilar opacities which could relate to interstitial edema or nonconsolidating pneumonia. Constellation of these findings could relate to fluid overload or congestive heart failure. Response to treatment: Able Final Plan: Patient was evaluated by ENT and recommendations admit patient to stepdown for continuous monitoring the airway and complete a treatment of 3 doses of steroids. After ENT evaluation patient does not appear to have any posterior oropharynx edema or swelling. His chest x-ray showed mild vascular congestion patient was given 1 dose of Lasix 20 mg IV. Final Diagnosis: Anaphylaxis due to COVID vaccine
swelling at the injection site; redness at the injection site; warm at the injection site; Tiredness; Headache; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 61-years-old female patient received BNT62B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22May2021, as 2nd dose, single dose (at the age of 61-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT62B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 01May2021 as 1st dose, single dose for covid-19 immunization. On unspecified date of May2021, patient experienced swelling, redness and warm at injection site and stated that she had some tiredness and headache. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
trouble breathing; swelling in my throat; rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate). At the time of the report, DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (swelling in my throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications was not provided.
cellulitis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8733, expiration date unspecified), intramuscularly, administered in Arm Left on 03Apr2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient medical history included type 2 diabetes mellitus (ongoing) Pertinent Details: 2018 Oct-Stomach gastric sleeve, sleep apnoea syndrome from 1999 and ongoing Pertinent Details: BI PAP Machine, spinal stenosis for 9 years (ongoing) Pertinent Details: Cortisone ingestions knees, brain and neck. The patient family history included cardiac failure congestive in 2002 to her mom, emphysema in 1988 to her Dad, which cause his death. The patient had x-ray of pelvis and hip on an unknown date in Nov2020 and results indicated lumber tailbone, fractured tailbone. The patient's concomitant medications were not reported. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6207, expiration date unspecified), intramuscularly, administered in Arm right on 13Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. On 06Apr2021, the patient experienced cellulitis. On 20May2021, the patient had her bone density checked and results are unknown at the time of report. The patient was treated with immediate care and received antibiotic shots for 7days. The outcome of the event cellulitis was reported as recovered on 21May2021.
bruise on arm after COVID Vaccine; This is a spontaneous report from a contactable consumer.   A 33-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced bruise on arm after COVID vaccine but didn't have anything else. Felt absolutely fine. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
dizziness; stuttering; ataxia; memory loss; This spontaneous report was received from a physician referring to a 11 years old female patient. The patient's concurrent included anxiety, depression and seasonal allergy. The patient's medical history included constipation. She had no concomitant medication or drug reactions/allergies.  On 01-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R019469, and expiration date 10-APR-2021) (strength and dose not reported) intramuscular for prophylaxis.  On 08-JUL-2019, the patient experienced dizziness, stuttering, ataxia and memory loss (not detailed further). On 01-AUG-2019 and 08-AUG-2019, she was seen by a neurologist, who prescribed propranolol (dose and frequency not specified). Magnetic resonance imaging (MRI) and computerized tomography (CT) scan were performed and showed negative results. On 29-AUG-2019, the patient recovered from dizziness, stuttering, ataxia and memory loss. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. No product quality compliance was reported.
Client states that for approx. 7 or 8 days, in the AM, felt feverish, aching and flushed. States did not correlate symptoms to vaccine. 2 days following, had a rash from head to torso with itching. Went to ER and MD told her she had measles from vaccine. Benadryl Rx given and it resolved in 4 days following.
I started off with a dry cough, sweats, fever, chills, body aches, and headaches. I took some Mucinex and Tylenol. I'm using an inhaler. I started on some melatonin to help me sleep.
Very mild H/A with dose #1. None with doses #2 & #3.  Dose #4; severe muscle weakness and joint pain, dizzy/lightheaded, fainted X1.  N/V, tinnitus, foul-smelling loose stools, lower back pain, & runny nose. Resolving but so slowly.
7/19/13 Tdap. 7/20/13 chills, 101 degrees, severe headache. 7/21/13 T 100 degrees. 7/22/13 afebrile - cont to complain of painful site, redness, pruritus.
/28: COVID + at home  2/2: Presents to ED with SOB; COVID +; admit    2/7:   2/9:   2/12: Trans to MICU as PCU overflow; cont BIPAP  2/14: Intubated; CVC & A-line placed. CTA + R pulmonary embolism; IR -> suction thrombectomy of R PE  2/15: R IJ Quinton placed; CRRT; DNR  2/20: CRRT stopped  2/21: Trans to HD, MWF  2/22: Tolerated CPAP 10/5, 40% ~ 4.5 hours; 1 PRBC  2/23: Levo gtt & sedation off  2/24: CT head (-); CT abdomen + pneumomediastinum  2/26: Neo gtt and sedation restarted; 1 PRBC  2/27: Neo changed to levo; foley xchanged; CVC d/c'd. picc placed  2/28:  Quinton removed  3/1:  A-line removed, new quinton placed, CRRT restarted 3/1 Pneumothorax and emergent chest tube-DNR 3/2 asystole; TOD 02:34
Her father has COVID 19 and was Vaccinated with the Pfizer vaccine in Feb; Her father has COVID 19 and was Vaccinated with the Pfizer vaccine in Feb; diarrhea; This is a spontaneous report from a non-contactable consumer via a Pfizer representative reported for father. A 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 at single dose for COVID-19 immunisation. Medical history included Covid-19. Concomitant medication was not reported. The patient had COVID 19 and was Vaccinated with the Pfizer vaccine in Feb. He had cough and diarrhea. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient experienced more adverse reactions to SHINGRIX than expected.
When technician was administering the dose needle retracted prematurely outside of the arm and patient did not receive the whole dose. contacted gsk/shingrix manufacturer and anything less than <0.45ml is and invalid dose and CDC recommends revaccination with an underrage the same day.
He experiences no pain but when lifting weights or using shoulders to exercise, his arm the shot was given in becomes too weak to continue and he has to stop
Temperature 103F and limp. Visited ER X 3 over the weekend. Tylenol and ibuprofen given throughout the weekend.
After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up.  The gout pain was so intense even after taking two pain pills, it kept me up all night.  I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week.  I was even getting up 2-3 times on some nights gasping to breathe.
This case was reported by a pharmacist via call center representative and described the occurrence of renal failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced renal failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the renal failure was unknown. It was unknown if the reporter considered the renal failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's husband came into the pharmacy and told that after his wife (patient) received SHINGRIX, she had kidney failure and was hospitalized for a month. Neither reporter could remember the patient's demographic information and they never heard any follow up for how patient was doing at the time of reporting.
Information has been received from a physician concerning a female patient who on 09/13/2002 was vaccinated subcutaneously in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 0381M, not a valid Lot # for the product).  Subsequently the injection site developed a small area of redness and was tender to touch.  Unspecified medical attention was sought.  Additional information has been requested.
Significant, half-grapefruit-sized swelling, bruise at injection site, lasted 1 week.
Caller diagnosed with COVID 19 after 1st Pfizer vaccine dose.; lost my sense of taste and smell; lost my sense of taste and smell; This is a spontaneous report from a contactable consumer via Medical Information Team.  A 28-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was diagnosed with COVID 19 after 1st Pfizer vaccine dose, states that received his 1st Pfizer vaccine dose on 26Mar2021 and then lost his sense of taste (ageusia) and smell (anosmia) and got diagnosed with COVID 19 on 02Apr2021 results on 04Apr2021. Patient Got clearance, this past Thursday (08Apr2021) or Friday (09Apr2021), that it was ok to leave Isolation 2nd vaccine dose is on 16Apr2021. Is it ok for me to get the 2nd dose? The outcome of the event covid-19 was recovered while for other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
high fever 102.5, excessive crying, over 3hr;pt had shakes & tremors for over 3hr;since that time pt has hand shaking & gross motor skills are delayed;pt is to see neurologist
flu like symptoms; lips were a little swollen on the side where she received her shot; This is a spontaneous report from a contactable physician (patient) via a sales representative.     A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Jun2021 (a day or two ago) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On Jun2021, patient experienced flu like symptoms and lips were a little swollen on the side where she received her shot. The outcome of both the events was unknown.  Information on lot/batch number has been requested.
Pt cried x 3 hrs mom was not able to console; no tx @ time of incident;
Severe burning in legs the night of injection.  Extreme soreness in arm for 4-5 days and could not move it.  After about 4-5 days, could move arm slightly, but could not lift more than 30 degrees from resting at side. Extreme pain with movement of arm or trying to use it.
Moderna vaccine was inadvertently administered past the 30 day use by date.  Moderna was contacted with this information and case ID number is CEA-1917.  No reports of any signs or symptoms at this time.
adacel vaccine reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192654 (same reporter).  This case involves a 19 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA and Exp. Date 24-Apr-2021) via intramuscular route in unknown administration site on 09-Jul-2019 .  The patient's medical history not reported and concomitant medications not received.  It was an actual medication error case due to incorrect product storage. Adacel reached 33.5C.  It was unknown whether the patient experienced any adverse event post vaccination.  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.
Several days after VARIVAX vaccine developed moderate amount of redness and swelling - no one measured - ice and BENADRYL.
After completing the 15 min monitoring, pt stated he had a sensation of increasing his heart rate.   EMS took his vital signs BP 108/80, HR 78, OxSat:100%.  After evaluation , pt stated he feels better.  Pt was with his partner and he was escorted by her to his car.  Pt was advised to inform his PCP about this.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Patient began having pain, soreness, and limited range of movement severals after administration and has continued until present time.
22 yo female presented on 26 Nov 2017 c/o some swelling and redness over left shoulder after anthrax shot 2 days ago on 24 Nov 2017. Pt is otherwise doing well, and denies F/C, systemic sxs, significant pain, or restricted arm ROM. Exam of left shoulder with 4 cm x 6 cm elliptical area of mild erythema and mild swelling, with minimal tenderness but no warmth or streaking. No treatment other than observation and Motrin prn.