chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel to be a simple common cold; Sore throat; Head cold; Cough; On a scale from 1 to 10 their sickness level is about a 5; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feel to be a simple common cold), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Head cold), COUGH (Cough) and ILLNESS (On a scale from 1 to 10 their sickness level is about a 5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Feel to be a simple common cold), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Head cold), COUGH (Cough) and ILLNESS (On a scale from 1 to 10 their sickness level is about a 5). At the time of the report, NASOPHARYNGITIS (Feel to be a simple common cold), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Head cold), COUGH (Cough) and ILLNESS (On a scale from 1 to 10 their sickness level is about a 5) outcome was unknown.             Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: AE details and outcome added
Body aches, headache, raised rash that made my skin feel like it was on fire, numbness to the tongue
Patient had severe soreness of the arm for 2 days, then was experiencing chest pain so went to the hospital on the 3rd day. (patient is on Ranexa so has prior issues with chest pain).  EKG and chest xray was normal and received pain meds from hospital which helped.  Patient saw cardiologist on the 3rd day after and everything was normal.  Patient still has some soreness but is much better.
Heavy chest/heart pain and tightness for around 12 hours. Lungs were burning and had a cough for around 12 hours as well. Slight nausea for around 1 hour.
pt vax hepta B., 2-3 weeks later pt c/o fatigue and malaise.  lab exal revealed SGOT 108 and SGPT 43 and anti-HBs neg along w/ tests for mononucleosis and cytomegalovirus.
Patient complained of  Light headedness, nausea, and tremor.  These symptoms would come in waves over one and half hour. At 1:25pm BP was 168/91 and HR 108.  He stated that symptoms had stopped at 2:45 at which time BP was 142/93 and HR 95
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 01-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L039095, expiry date: 08-JAN-2017). The patient experienced shingles on 03-MAR-2016. Patient reported that she noticed a rash on her body on 29-FEB-2016, day before vaccination with ZOSTAVAX. She contacted the pharmacist on 03-MAR-2016, for a prescription regarding VALTREX. She informed the pharmacist that she thought that ZOSTAVAX would treat her rash. Patient required medical attention and consulted her physician on the same day, to seek treatment for the rash. The physician diagnosed her with shingles. It was unknown if the patient had shingles before receiving ZOSTAVAX. At the time of this report, the patient has not taken any doses of VALTREX. Outcome of the event, shingles was unknown. Reporting pharmacist did not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information has been requested.
Has a large swelling on thigh and the swelling is red. Child complains that it itches and hurts. Patient had redness and edema of right thigh at the vaccine site that was warm to the touch (R) thigh.
p/vax pt found dead by husband on 10/7/99;it was reported by pt husband that on 10/6/99 pt had a cough & chest congestion;pt was never seen by MD not in whole life;pt always treated self w/all kinds of herbs & vitamins;
Edema in hands that hasnt gone away; Changes in vision; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 41 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medications included: WELLBUTRIN.  The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Edema in hands that hasnt gone away"; VISUAL IMPAIRMENT (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Changes in vision".  Therapeutic measures were not taken as a result of oedema peripheral and visual impairment.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o: dizziness, weakness of muscles in both legs, stomach upset, and chills 1 day after vaccine.  Pt was advised to go to ER.
pt recvd vax 13OCT95 & phoned clinic on 16OCT95 to report began breaking out in hives about 1 hr p/vax; took DPH which had @ home;14OCT95 reported to hosp ER w/hives all over;
Pt. received vaccines on 8/10/16. Fever started on 8/10/16 of 102 F and TYLENOL given. Then rash developed and became severe morning of 8/11/16. Mom brought pt. clinic and Rx given for BENADRYL and advised to give TYLENOL.
Pt said about an hr after she got the shot she got blurry vision then numbness in her hand/arm then numbness/tingling in mouth/tongue.
Pt was given vax w/no problems noted went to bed as usual about 830; t101; up off & on all noc crying;
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 16-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
mild chills; FEVER; lethargy; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026A21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy). At the time of the report, CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.
1. Mild fever, 3/29 evening treated with Tylenol. Subsided 2. Trigeminal neuralgia, started 4.00 pm on 3/29. Ongoing. Treating with carbamazepine and ibuprofen.
Patient did not have any adverse events.   She tolerated vaccine, Developed COVID infection 12/28/20 and recovered 01/21/21 She died due to her cardiomyopathy
p/vax pt had chickenpox approx 80 bumps;denies other c/o;did not require follow-up;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-DEC-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L006384, expiry date: 25-FEB-2017; dose and route were not provided). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a county health nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients may had been vaccinated with improperly stored GARDASIL (dose, route, lot numbers and expiration dates were not provided). Excursions began on 08-JAN-2014. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Less than 10 minutes after receiving one dose Havrix 1440 ELU/ml IM left deltoid, pt falls forward lands on chairs.He was observed by me & talking with me until his fall.I was assisted by tech to get pt to ground & made sure pt was breathing & had a carotid pulse.I turned him on his back while my tech got my BP monitor-first BP was 110/45,P48 @ 10min post injection. I maintained q2min BP checks.No signs of allergy-I asked about swallowing, tongue, observed eyes, skin - no redness.  Maintained conversation with pt who answered appropriately.He tried to sit up @ 6Min, but became dizzy so I laid him back down & continued BP q2min. Paramedics arrived @ 21min after initial tx by me.They gave no meds, but advised transport since they detected a possible arrhythmia on EKG.
Patient got a mammogram on same day and later experienced a rash on her face and chest. Ambulance was sent to pick her up and she spent two days in the hospital. She was afraid the rash would scar, but it seems to be clearing up.
Severe arthritis symptoms. I have psoriasis and suspect shot caused inflammation, a psoriasis trigger.  Never had arthritis in arms, now it's difficult to dress.  Started right after second shot.  Taking Tylenol but it doesn't help a lot. Hip pain as well, and right thumb. Knees had arthritis, but are worse now.
Pt recvd vax 12NOV93 & 2 to 3 days later pt devel a viral infection w/GI sx followed by upper resp sx; devel lightheadedness, malaise & diarrhea which resolved p/5 days; devel opthalmoplegia of 3rd & 6th cranial nerve was hospitalized; GBS
Pain in shoulder; Pain in top of arm; Pain going up to neck; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METFORMIN, BACLOFEN, FOLIC ACID and ROSUVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck). At the time of the report, ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck) outcome was unknown.            Treatment information was not provided. The reporter mentioned that the patient was undergoing a heart catheterization at the time of the report.
This spontaneous report as received from a registered nurse refers to a currently 46 years-old female patient. On 08-NOV-2016, the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced rubella antibody negative. The outcome of rubella antibody negative was unknown.       Additional information has been requested.
A rash broke out on my legs (mostly on my thighs, but a few near my ankles and a few on my butt). It itched for about 36 hours, then stopped itching. Benadryl Extra Strenght Itch Stopping Gel (Diphenhydramine Hydrochloride 2%) relieved the itching. Today (03/16/2021) the spots are smaller but are still visible.
Extreme weakness and fatigue.  Could not walk, could not stand, could not lift head.  Had to lift her to a portable toilet.   Slow to respond.  Lasted for about 3 days and then started to improve each day.  Took about about 5 days to be back to pre-covid vaccination state.
Fever at 100.0 F; A spontaneous report was received from a consumer (patient's husband) and concerning 50-year-old, female patient who was administered Moderna's COVID-19 vaccine(mRNA-1273) and experienced a fever of 100.0 F (Pyrexia).    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot 011J205A) intramuscularly in the right arm, for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient had a fever of 100.0 F.  The patient had not received any treatment for the event at the time of this report.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of fever of 100.0 F was not resolved.; Reporter's Comments: This case concerns a 50-year-old female with a NS expected event of Pyrexia. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt states that on her way home from the store her feet became itchy. By the time she got home it was all she could do to get up her stairs as her feet were incredibly itchy and red. States she had this kind of reaction to a different medication she was allergic to.
After 15 min receiving  2nd dose Moderna vaccine (Covid) left hand, lips, face and chin numbness and tingling.   Light headed.
Blister like rash reported on R thigh with a lump in center. Mom thought it was a bug bite.
patient developped rash only on her face the second day , it took almost a week to get better  also patient complained of aches in her body however there was no fever advised patient to take claritin and advil if needed and monitor the symptoms
Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200463210 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "unknown", described as "Rash". Therapeutic measures were taken as a result of rash.  Additional information: It was reported that the patient got the booster in Jan2022 and she had a rash and she has been taking Benadryl 3 times a day and Caladryl.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Blister rash on both knees and elbows. Treatment triamcinolone cream.
Pt recvd 1st dose of Hep B vax on 25JUL91 & devel h/a, myalgia, arthralgia & vomiting on 26JUL91; No further details were provided;
Injection site was red and swollen with hard lump underneath skin.  Arm was hot and painful to touch at left deltoid area.  Diagnosis of cellulitis.  Patient treated with Bactrim PO.
tingling face; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. An unspecified age non pregnant female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, in Left Arm on 27Feb2021 as 1ST DOSE, SINGLE for Covid-19 immunisation in workplace clinic. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive other vaccines in four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. The patient was not diagnosed with COVID, prior vaccination. Since vaccination, the patient was not tested positive for COVID. On 27Feb2021 at 3:00 PM, the patient had experienced tingling face. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number can not be obtained.
Pfizer vaccine was administered outside of the source - reported by patient  R09.02 HYPOXIA 12/19/2021 HEMATURIA R09.02 HYPOXIA 12/19/2021 BLADDER CANCER, LOCALIZED, UNSPECIFIED SITE R09.02 HYPOXIA 12/19/2021 HYPERLIPIDEMIA
patient did have a little flu like symptoms; Initial information regarding an unsolicited valid non-serious case was received from  a healthcare professional via the agency (Reference number- 00360277) via the call center and transmitted to Sanofi on 16-Nov-2020.  This case involves a 52 year old female patient who had little flu like symptoms (Influenza), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 13-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number UJ211AA Expiration date: 30-Jun-2020, standard Strength) at a dose of 0.5 mL via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient mentioned that she had a little flu like symptoms (Influenza) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for Influenza.
Severe body inflammation. Problem worsened a month after booster. Couldn't raise arms all body hurt with swelling.
Describe events and outcomes:   Abrupt onset of palpitations on the morning of March 22, 2021. Went to previously scheduled medical appointment where they found my pulse rate to be over 200. ECG was performed and atrial fibrillation was diagnosed. Transported by ambulance to Hospital. Spontaneous conversion during the ambulance transport. Duration of symptoms: approximately 3 hours. Non-ST Elevation MI diagnosed in the hospital. Echocardiogram showed pericardial effusion. Hospitalized 1 day.
The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.; No adverse event; 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022, Beyond use date was 05-Aug-2022, Dose was administered form 19-SEP-2022 until 09-NOV-2022.).    No concomitant medications were reported. It was reported that 3 Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-Jul-2022 which had beyond use date of 05-Aug-2022. 12 Adult patients received expired monovalent dose of Moderna COVID-19 vaccine from 19-Sep-2022 till 09-Nov-2022, out of which 9 were 3rd booster doses and 3 were second doses. No previous excursions happened.  The vial was initially stored in the refrigerator on 06-Jul-2022. The doses were administered as 6 patients on 19-Sep-2022, 2 patients on 04-Oct-2022 and 1 patient on 09-Nov-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live Follow-up : Narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:Master case
Expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient was on concomitant medications. No treatment details were reported.  Reporter also stated that patient did not experienced any symptoms.
Chills, fever, aches, headache about 20 hours after vaccine was administered. It was my first dose but I think it?s important to note that I had Covid-19 in July/August 2020.