chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; Vomiting; Dizziness; Fever; Nausea; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8730) via an unspecified route of administration in the arm left on 05May2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included montelukast sodium (SINGULAIR) and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) both taken for unspecified indication from an unknown date. The patient previously took morphine and experienced allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 07Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 20:00, the patient experienced sweating, vomiting, dizziness, fever, nausea and pain in arm. The clinical outcome of the events sweating, vomiting, dizziness, fever, nausea and pain in arm were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Noted itchy rash starting in abdomen "little bigger than quarter." Rash has spread to top of thighs, stomach, back of right arm, under neck and upper chest area. Client states she had strep throat approx 3 weeks before seeing MD. Given antibiotics.
Five days after shot stinging, burning pain, L side front and back from spine below waist around body, into groin area and under stomach, down front of L leg to knee.  Saw doctor on April 5, 2:p.m.  for signs of diverticulitis, given Flagyl and Cipro antibiotics, asked if there was  any rash. There was not.  Pain that evening radiated through entire lower half of body, burning of skin intense.  Went to ER. April 6, before 10:00 a.m., thinking I might have a ruptured diverticuli, for which I had major surgery 4 years prior.  CT scan returned a "mild diverticulitis".  Rash appeared under skin on L upper thigh on 4/8/21, looking like measles spots.  Called doctor's office 4/9/21, thinking allergy to antibiotics given for diverticulitis.  My records showed I had been on both before with no reaction; nurse and doctor determined by description and having seen me earlier in the week that it was shingles.
Fever of 100.5 F; Headache; Chills; Tired; Flu-like symptoms; Arm was sore; A spontaneous report was received from a consumer, concerning herself, a 61-year-old female patient, who received Moderna's COVID-19 vaccine and experienced flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced soreness in her left arm and on 30-Dec-2020, she developed fever of 100.5 F, flu-like symptoms, headache, chills and fatigue. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcomes of the events, flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired were not-resolved and was ongoing at the time of this report.; Reporter's Comments: This case concerns a 61-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the non-serious unlisted event of flu-like symptoms, and the non-serious listed events of arm sore, fever, headache, chills, and fatigue.  Based on the current available information and temporal association between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Extreme chills for nearly two hours followed by 103 fever, fatigue, nausea, headache.
Localized reaction to right thigh. 23" in length 26 1/2 diameter. Pt treated with Augmentin 400/5 6cc Bib x 10 days for cellulitis.
She has since tested positive for Covid after the first dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration (left arm) on 03Feb2021 17:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies to sulfa from an unknown date. Patient is not pregnant during vaccination. Patient did not have COVID prior vaccination.  Concomitant medication included escitalopram oxalate (LEXAPRO), therapy date and indication unspecified (other medications in two weeks). No other vaccine in four weeks. The patient experienced she has since tested positive for COVID after the first dose, on 08Feb2021 16:00 via Nasal swab (also reported as 04Feb2021 and 07Feb2021). No treatment given. She was asking if she should get the second dose. Outcome of the event was reported as recovering. Reporter considered the event was non-serious.  Information on the lot/ batch number has been requested.
He received  a second dose of Moderna covid vaccine on 5/27 and progressed to develop some lethargy and decreased oral intake over the following days. When he arrived in the ED on 5/31 his temperature was 30.0?C rectally and bradycardic (HR51), BP 115/81, mentally altered. No evidence of infection or worsening of existing chronic conditions.  he was admitted to ICU for hypothermia.
A patient received an expired dose of Fluzone vaccine/No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 50 years old female patient who received an expired of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number: UJ223AA, expiry date: 22-Sep-2020) via un unknown route and site on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine used.  At the time of report 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.
felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the deltoid muscle and bleeding; bad bruising on the deltoid muscle and bleeding; This is a spontaneous report from a non-contactable consumer reported for his son. A male patient in his 30's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 (at age of 30's, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his son had the first dose of the Covid-19 vaccine on 12Apr2021 and ten days later he presented "something like burning feet, felt a cold and then hot burning mostly at night, felt like he ran a marathon and felt like his legs were heavy". Stated that the side effects resolved after 24 hours. Added that his son was in his 30s. Stated that the vaccine administrator had a poor technique and his son presented bad bruising on the deltoid muscle and bleeding. He had no preexisting condition and would like to find out if this event has been reported. Reporter would like to consult if his son should get the second dose of the Pfizer Covid-19 vaccine if he presented side effects after the first dose. The outcome of the events "Feeling hot and cold/ Heaviness in limbs" was recovered on 23Apr2021. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching/ itching" all over after getting her 1st dose of Shingrix.; This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter was Medical Assistant.  The reporter that another medical assistance in the office experienced itching all over after getting her 1st dose of Shingrix. The reporter did not consented to follow up.
pt recvd vax early PM & exp swelling & heat & t103; next day AM exp reddness & swelling to elbow t104; 10PM began facial contortions, twitching, & eyes rolled in head & eyes jumping; this would last 30 mins;
No adverse effects reported; expired dose of ROTATEQ.  Expired on 10/9/2023 and was administered today 10/16/2023.; This spontaneous report was received from a nurse and referred to a 9-week-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 16-OCT-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milligram, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength was not provided) (expired vaccine used). No adverse effects reported (no adverse event).
little bit of arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of arm ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer stage IV (terminal cancer patient).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of arm ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of arm ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was on several medications but did not mention them.   The patient received vaccine in unknown arm.   This case was linked to MOD-2021-326213 (Patient Link).
Deep red welt at vaccination site. Redness expands from site and cover majority of inner forearm. Arm is itchy and warm.
pt recv vax 23OCT98 & that noc lt leg began to swell & sustained fever up to 104;hosp 24OCT98-28OCT98 p/developing erythema, massive swelling, pain in the leg;
Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer monovalent.
Severe pain and muscle spasms in left underarm and radiating down to left elbow area; also tingling in left arm and numbness in fingertips in left hand.  The pain was so severe that I was barely to get out of bed and missed approximately three weeks of work.  Symptoms continue to this day but are much less severe after receiving physical therapy (electrical stimulation and ultrasound massage).  Anti-inflammatory and nerve pain drugs did not reduce the pain.  After eliminating neuropathy, brachial plexus neuritis, hematoma and other possible nerve damage, it was diagnosed by doctors as severe muscular/fascial/nerve sheath inflammation caused by the seasonal flu vaccination.
Pt received FLUMIST and VARIVAX, within few minutes had profuse vomiting and severe abdominal pain with perioral cyanosis. POX 97-100%.
LEG PAIN; This spontaneous report received from a consumer concerned a female 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: 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 subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious.
Breakthrough case admission after 3 vaccines  Pfizer 1/1/21 Lot# El3249; Pfizer 2/12/21 Lot# El9261;  Pfizer 11/17/21 Lot# FH8028
2hr p/vax pt started excessive coughing & having rapid, shallow breathing lasted approx 4hr;
REDNESS FROM SIGHT OF INJECTION TO BASE OF ARM, NEAR THE ELBOW. PAIN RADIATING DOWN TO THE HAND. HOT/WARM TO THE TOUCH AND FEEL OF THE PATIENT.
Developed few hives late in the evening after receiving vaccines.  Seen in office aprox 24 hrs from vaccine-broken out head to toe in hives. Given oral benadryl 25 mg in office and 12 mg of Depo medrol with oral prednisilone to follow starting the following day.
Onset of (L) shoulder pain limiting mobility about 3-5 hours after vaccine given. By 9-24-12 was starting to improve. Recd topical ASPERCREAM to site.
At 10:40pm, i was awakened by a high heart beat, approx 86 while sleeping,  then had very short breath which i had to deep breath for about 2.5 hours ,  plus shakes,  headache , and body aches,  after about 3-4 hours i fell back to sleep and the next day at 12 noon,   Everything was back to normal and totally fine.
Right-side head and tenderness, same dermatome as previous shingles outbreak.  Redness and small blister on top of right ear.  The head pain is hard to bear.
Shingles presented itself approximately 10 days later from Date of Vaccination, which was on 9/20/08.  On 10-1-08, morning shingles were present and confirmed by emergency care and Family Physician.  Investigation was due to Husband broke out with hives on 10-1-08 after being vaccinated on 9/20/08.  The correlation between the two outbreaks resulted in the the vaccination resulted in the outbreak.
swollen lymph node, same side of vaccine; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 27th August 2020) for prophylaxis.   On 16th August 2019, the patient received Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on an unknown arm. The day after vaccination, the patient had her scheduled mammogram done. The patient was then contacted and was told that the mammagram showed a swollen lymph node on the same side that she had the vaccine. The reporter did not consent to follow-up. No further information was available. The provided information regarding lymphadenitis to the intern from Shingrix prodcut information.
Left arm -Pain with lifting arm, tingling, disfunction with ability to move arm (almost like when your arm falls asleep), isn't tracking smoothly. It started around 1730 on the day of her injection.   Under section 21. Disability or permanent damage was selected due to unknown outcome at this time as patient is currently still experiencing symptoms/signs.
Nurse administered Zostavax intradermal on left forearm. Patient had immediate itchy reaction followed with swelling and tender/hot to touch.
Nurse noted few minutes after shot - Pallor, Shaking, LOC for 40 seconds - syncope. Called doctor and had patient lay down. Given oxygen by mask. BP normal, no bronchospasm or respiratory distress on examination. Responsive to name and able to answer questions. Felt better with improved color and able to ambulate on own w/in minutes. F/U call in few hours, patient had low grade fever, soreness in arm where other shot given, but felt well w/o dizziness.
Chills but no fever for 12 hours Fatigue to the point of requiring sleeping Sore arm
At 5:50 pm, TB felt pain(mod-severe) in L/arm (deltoid area). Over the next 1-2 hrs she experienced itchiness, rash, swollen face, difficulty breathing & wheezing. Went to ER 11:00 pm, given Solumedrol & Benadryl & Nebulizer Rx & released.
Feelt very tired; loss of consciousness with fainting; Felt like her throat was closing; Chills; A spontaneous report was received from a consumer concerning a 25-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, felt like her throat was closing, chills and felt very tired  The patient's medical history was not provided. No relevant concomitant medications were reported. Laboratory data was Prolong QT interval on ECG reported.  On 20 Jan 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, 5 minutes after vaccination, the patient felt  like her throat was closing, chills, lightheaded and fainted. In the ER the work up for syncope revealed prolonged qt interval on ECG. Treatment included Benadryl, Magnesium, fluids. The patient was discharged on the same day but she still feels tired having brain fog.   Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of events were not reported; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient c/o fever, headache, myalgias, weakness on 2/4/2021. Presented to ED 2/6/2021 with above symptoms and shortness of breath.
Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the whole right arm from shoulder to fingertips.
This spontaneous report as received from a nurse refers to a 39 year old female patient. No medical history and current conditions were reported. On 11-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J014152, Expiry: 07-NOV-2015) (0.5 ml, subcutaneous). No concomitant medications were reported. On 12-MAR-2015 (reported as within 24 hours) the patient experienced injection site reactions, 4-inch oblong area with significant swelling, redness, inflammation, itching and the injectio site was warm to touch after receiving (Oka/Merck) VARIVAX. Nurse reported she used the sterile diluent provided, but had not recorded the lot number. Patient received treatment with ice compress. The outcome of the events was reported as recovering. The reporter causality was not provided. No further information was provided. This case is linked to MARRS# 1503USA010703 with the same reporter link. Additional information has been requested.
Hives in armpits, then progressed onto torso and a few on sides of leg. No other symptoms. No treatment, resovled on own.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of DISORIENTATION (Disoriented) and VOMITING (Throw up 4 times in a row like a lot) in a 14-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Patient had no allergies with medications, food and other products.  On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Throw up 4 times in a row like a lot). On an unknown date, the patient experienced DISORIENTATION (Disoriented). At the time of the report, DISORIENTATION (Disoriented) and VOMITING (Throw up 4 times in a row like a lot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient mother reported that the events throw up 4 times in a row like a lot and disoriented symptoms were improved. No acute or chronic illnesses were reported. Patient height reported as 30 inch 2 months ago. Patient was immediately monitored by her pediatrician after the adverse events. No concomitant medications were reported. No treatment drugs were reported.
Freezer temperature excursion- 12.1 degrees F.  Vaccine administered. No adverse event for patient reported. Data logger determined to be off on calibration with troubleshooting efforts. Replaced and working properly.
Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fever (Tmax 101.8). Last day of work and shift - ? supposed to work tonight but called off due to feeling ill Home remedies? -   Tylenol at 0740 and sleep Any improvement? ? mild improvement Recommendation? EE educated to continue to monitor symptoms and call vaccine support with further concerns or questions.  EE educated of changes in RedCap Survey and educated will need to be fever free for 24 hours before returning to work.  EE reports she called off of work tonight as she is not feeling well.  EE educated to continue to manage her symptoms and to follow the guidelines outlined in the TCH Illness in the Workplace Policy.  EE denied COVID-19 exposure without proper PPE and denied travel.  EE verbalized back understanding and denied further questions at this time.
Mom reports that baby was inconsolable for about 7 hours about 8 hours post vaccination. Mom did give TYLENOL when baby would not calm down and baby did settle down after that. No fever or redness at sites.
BODY ACHES; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache. This report was non-serious. This case, involving the same patient is linked to 20211128598.
Patient received second dose on 3/13/21. In mid-april, patient started experiencing numbness, tingling, parasthesias, and weakness in the lower extremity. This progressed upwards over a period of 2 months with worsening weakness. Due to the symptoms the patient fell and broke his ankle. The patient eventually could no longer walk as the weakness progressed. On MRI the patient was found to have an extensive transverse myelitis and was admitted to the hospital 06/18 for steroid treatment.