chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report (United States) was received from a patient concerning a 80-year-old, male patient,who received Moderna's COVID-19 vaccifene (mRNA-1273) and experienced  sore in her arm, injection site reaction like injection site rash, injection site erythema, injection site warmth, red and hot and kind of itchy. The patient's medical history was not  provided by the reporter. Concomitant medications reported included eicuted (blood thinner), pilutacion, pills for depression, liver low zero, function, baby aspirineAcetyl salicyclic acid), night ambiom for sleep, vitamins. On 03-FEB_2021, approximately six days 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 03_FEB-2021, prior to receiving mRNA-1273, the patient felt sore in her arm, injection site reaction like injection site rash, injection site erythema, injection site warmth, red and hot and kind of itchy. lab report results were not provided. Treatment for the events were not included. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of the events were not recovered or not resolved. Based on MSA comment, sore in her arm change to vaccination site pain and listed in all RSIs
Patient stated that she had a lump under the skin at injection site that was hot to the touch. She also stated that she had a fever. Pharmacist referred her to urgent care to seek medical attention.
Throat tingling; Throat swelling; Drainage; Fever; Joint aches; Chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever) and ARTHRALGIA (Joint aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (5 months ago the patient had COVID-19). Concomitant products included GLIPIZIDE, IRBESARTAN, ALPRAZOLAM, LINAGLIPTIN (TRADJENTA) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Feb-2021, PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 24 hrs of receiving Fluzone flu vaccine developed rash (L) upper chest and neck, then (R) maculopapular "drug" rash in appearance. Employee contacting private physician.  Headache also. (Reported 11-1-07)
unable to dress themselves without assistance; pain, soreness,/in the left arm/soreness quickly progressed to pain/lasted for / two weeks; immobility of left arm /  had to use their right hand to move their left arm/ immobility last for 4 days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient received first dose of Shingrix at the end of May 2021, in her left arm. The patient experienced pain, soreness and immobility in the left arm. The reporter stated that, soreness began the evening of the day the first dose was received. The soreness quickly progressed to pain and immobility in the left arm. The patient had to use her right hand to move her left arm. Less than 2 months after vaccination, the patient was unable to dress herself without assistance due to pain, soreness and immobility of left arm. The immobility lasted for 4 days. The pain and soreness were lasted for approximately two weeks and all symptoms have resolved. The reporter did not consent to follow-up.
6 month-4 year old vaccine administered mistakenly to patient who is 5 years old.
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis. Concomitant products included HEPATITIS A VACCINE (HAVRIX). On 8th December 2021, the patient received the 2nd dose of Havrix. On 8th December 2021, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: On 6th November 2021, the patient received 1st dose of Havrix. The patient received the 2nd dose of Havrix in right deltoid, earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Pt. c/o (Lt) arm pain a couple of weeks after injection administered. Informed pt to see Dr. Pt. placed on anti-inflammatories.
Tinnitus in both ears developed after second dose of  vaccine. Pitch gets higher when I open my mouth. Has not resolved and it?s over a week since my last dose.
18 hours after receiving the FLUCELVAX, the patient noted right side facial edema and difficulty with swallowing, ? fever. Did not seek medial treatment and no over the counter medications were utilized. All S/S had subsided by 2:00pm on 9/27/18.
Dizziness. Unsteadiness, not spinning. Constant whenever on my feet or walking. Not while sitting
Child has red, palpable lumps at injection sites.  Right thigh has red, discolored area 3x4cm, left thigh lump area is 2x3cm.
Patient stated he was having chills, achy and feverish. Stated that last year he was sick for a month after his flu shot (delirium, fever, chills, achy). Patient did not mention about his reaction last year when getting the shot and filling out the form. He figured it was a coincidence but had a similar RXN after this shot. Advised he see his MD. He said he didn't have one he trusts. Also that it was less severe and he was doing better than when he got the vaccine.
I had dizziness, headache, and extreme tiredness on the day of the injection.  The rash I had on my forearms flared up and became extremely red and itchy on Sunday (24 hours after injection) I have seen my doctor about it and received information about otc antihistimines and steroid cream to treat.. But I am on 4th  day following injection and still itching and red.  Chills, fever (100.8 occurred Sunday evening approximately 30 hours after dose ) Joint pain about 24 hours following injection. Redness, swelling and pain at injection site lasted approximately 3 days.  FYI - I had Covid19 infection test confirmation Date December 14, 2019.
Complained of several intermittent episodes of right arm numbness and tingling down to her fingers; lateral 3 fingers. Progressed over time.  Was seen by Neurosurgeon and sent to Neurologist.  Had MRI scan head, neck and shoulder. Then EMG study that revealed a brachial neuritis pattern on right.
injection site pain; tiredness; headache; muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:00 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. The patient's medical history included hiatal hernia, reflux, migraine and headaches. The concomitant medications included cholestyramine, colecalciferol (VIT D3), pyridoxine hydrochloride (VIT B6), cyanocobalamin (VIT B12) and zinc. The patient previously took amoxicillin, epinephrine and morphine and experienced known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Feb2021 21:30, the patient experienced injection site pain, tiredness, headache, muscle pain and joint pain. The patient not received treatment for the events. The outcome of the events was recovered in Feb2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 11 year old female, who on 24-OCT-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (Lot # not reported). Concomitant therapy included Havrix and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 21-OCT-2007, the patient fainted after vaccination. The patient was observed for 1 hour in the physician's office and was fine. Additional information has been requested.
Pt reported hives with 1st pfizer COVID vaccine but no reaction or side effects with 2nd. Advised to wait 30 mins after 3rd dose. At the end of 30 min wait, pt reported significant nausea and itching on arms and throat. PE: Chest CTA B/L; no erythema or edema of mucus membranes. Had pt wait for 15 mins longer in the shade and in car with AC. She reported increase in nausea and pruritis. Advised to go to ED for further evaluation.  She left the ED prior to being triaged.
Information has been received from a physician concerning a pt who was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (lot number not reported). Subsequently the pt experienced adverse event (unspecified). At the time of this report the outcome was unk. Additional information has been requested.
patient vaccinated with vial where pharmacist not sure if punctured or not; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   Reporter did not allow further contact
Patient had a allergic reaction to her 2nd Pfizer vaccine.  She experienced ichiness all over her hand, arm, back and stomach.
Received the above vaccine on 1/18/11 PM - when pt started with symptoms of fatigue & when on feet had othostatic symptoms (presyncopal) - next day same symptoms & pruritis without rash but resolved with BENADRYL - no symptoms on day of exam 1/20/11.
Fever with generalized seizure (lasted 7 minutes) - within 12 hours of vaccine administration.
32 weeks pregnant at time of vaccination On the next day following vaccination, noticed sudden hearing loss in right ear. Will start steroid treatment. MRI not yet performed.
77 year old  male presents with SOB x "2 minutes" after vaccination. Pt has multiple comorbidities and poly pharmacy. Pt. is accompanied by 2 daughters who states that he is late with taking medication. Pt is currently "feeling better" and has refused emergency medical transport, .
3 minute diagnosed Grand Mal seizure, never had a seizure before. No signs beforehand other than legs went numb immediately before falling to the ground. After the seizure witnesses confirmed I spoke with emts and answered questions but I do not remember anything for 20 minutes after the seizure began. It took about 45 minutes for my memory of the rest of the day and moments prior to the seizure to return.
rash all on her trunk/rash going down her arms/ rash going into her groin area; This is a spontaneous report from a contactable consumer or other non hcp.  A 54-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: was not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: was not provided) as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced rash all on her trunk/rash going down her arms/her groin area. Caller stated that she had her second Pfizer dose yesterday and has a rash all on her trunk going down arms into her groin area. She wanted to know if she could take Benadryl or what was suggested. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
day following vax pt exp arthritis like soreness at all joints, swelling at inject site. slight fever, tightness of chest when breathing
she should not have had ibuprofen before receiving the last two vaccines; sore arm; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140), via intramuscular route of administration in right deltoid on 11Jan2021 at 09:30 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation at assisted living facility for people with developmental disabilities, operated by help foundation where she was employed. Medical history included ongoing type 2 diabetes mellitus (diagnosed many years ago, about 7 years ago). There were no concomitant medications. Investigation assessment was not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. She was a head nurse for the "PRIVACY". Back on 11Jan2021, she had the first dose of the COVID vaccine. She was scheduled to return for the second dose on 01Feb2021 which she did. On 27Jan2021 she was admitted to "PRIVACY" and she had major surgery and was discharged a day and half later. She was put on pain medication. She did not realize at the time, that she should not have had ibuprofen before receiving the last two vaccines. She was fine with the first dose. She took 600mg of ibuprofen as an order from her surgeon. She has had zero side effects; she was wondering if by taking ibuprofen did, she destroy or reduce the efficacy of the vaccine. Her primary does not know about all this and she has not seen her primary since the surgery. Full contact details not available. She clarified she had two surgeries on 27Jan2021, she had back-to-back surgeries. She had a hysterectomy and had a sling placed for her bladder, states her bladder was hanging out of her body. She not sure what the second surgery was called. She was admitted at the "PRIVACY", states it was not insignificant when querying seriousness. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient received 1 dose (her 2nd dose out of the 2 dose series) of the Pfizer COVID-19 vaccine 5/18/21. While completing her monitoring time after the Pfizer COVID-19 vaccination, the patient claimed to be feeling nausea. The patient was led to a room to sit down and was given water if she would need it. The patient asked our staff to contact her husband to pick her up. The patient refused emergency help when asked and preferred to wait for her husband who came by and led her out of the pharmacy.
Localized moderate soreness, mild swelling in upper arm/bicep area per patient, barely visible, mild are of slight redness in bicep area. No actual redness or swelling at injection site visible. Advised client to use anti-inflammatory OTC as directed and use cold application 15 minutes on and 15 minutes off prn.
IMMEDIATELY AFTER THE INJECTION SHE COMPLAINED OF PAIN AT INJECTION, TINGLING DOWN ARM INTO FINGERS, OTHER ARM BEGAN TO FEEL THE SAME, BACK OF NECK GOT REALLY HOT FOLLOWED BY THE EARS DOING THE SAME, STARTED FEELING VERY LIGHT HEADED, BECAME VERY PALE AND LIPS TURNED BLUE, ARMS STARTED JERKING.  PATIENT STAYED ALERT THE ENTIRE TIME.  PATIENT DRANK SOME SODA AND USED COLD COMPRESS ON NECK.  AFTER 30 MINUTES PATIENT FELT BETTER.  SHE STAYED FOR 45 MINUTES WHILE WE MONITORED AND THEN SHE WAS ABLE TO LEAVE THE PHARMACY WITH A FRIEND.  CALLED NEXT MORNING AND SHE IS BETTER, JUST HEADACHE FROM THE VACCINE.
Left side (arm, shoulder, neck and side of face) swollen, painful and hot with body aches. Resolved in 12hours.
OPEN VIALS WERE LEFT IN THE REFRIGERATOR OVERNIGHT; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced open vials were left in the refrigerator overnight. On 23-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the out of specification product use and open vials were left in the refrigerator overnight was not reported. This report was non-serious.
Body Aches Chills Headache Low Grade Fever Arm Soreness Swollen Lymph Nodes GI Upset
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. On 18-JUL-2016 the patient received a first dose of ZOSTAVAX (0.65 ml) subcutaneously (concentration, lot # and expiry date were not reported). Then, on 31-JUL-2106, a second dose was given (0.65 ml) subcutaneously (concentration, lot # and expiry date were not reported. Additional information has been requested.
Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later
This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines GARDASIL on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008775:same reporter, US-009507513-1612USA008776:same reporter, US-009507513-1612USA006359:same reporter.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 9th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case