chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Muscle pain; Headache; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
RED ROUND HOT SPOT ON LEG 17CM BY 12 1/2CM
retinal tear; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (retinal tear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RETINAL TEAR (retinal tear) (seriousness criterion medically significant). At the time of the report, RETINAL TEAR (retinal tear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment information for the events was reported.  The patient noticed floaters in her left eye, 2 to 3 weeks after first dose of vaccine. The patient contacted her Ophthalmologist and was informed that she was having retinal tear.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035385, expiration date: 08-APR-2018, lot # M040269, expiration date: 28-APR-2018 and lot # M038846, expiration date: 26-APR-2018, orally, as prophylaxis. (Strength and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010795: US-009507513-1704USA010796:
contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 02Jun2022 as dose 3 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: High Blood Pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive, notes: He was diagnosed on 11Jul2022./ Date of start of reaction/event: 11Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: While reporting on herself the caller mentioned that the person that lives in the house where she lives is fully vaccinated and that is who she contracted Covid-19 from. The caller said that he also took Paxlovid with her. He took the same medication Paxlovid also. He was more ill than his wife was even though he was vaccinated. He was sicker than she was. He was diagnosed on 11Jul2022 with Covid and started taking Paxlovid on 12Jul2022.   No follow-up attempts are possible. No further information is expected
Low grade fever; Body ache/ Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain). The patient was treated with PREDNISONE for Pain burning, at a dose of 1 dosage form; DULOXETINE at a dose of 20 milligram and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 19-Feb-2021, PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: (High) 102 degree Fahrenheit on first day and (High) 100 degree Fahrenheit on second day. In March 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216580 (Patient Link).
At 3:50 PM, pt had an episode of syncope. Mother helped client to lay down on exam table. At 3:51 PM, client alert and oriented. Vital signs: BP 108/60, 78. Lying on exam table, juice given. At 4:45, 108/68, P 68.
10/27/2020 tested positive for Covid PCR 1/21/2020 Covid vaccine #1 Pfizer 2pm EL 9261 IM L/Arm 2/11/2021 Covid vaccine #2 Pfizer 3pm EM 9809 IM R/Arm 4/6/2021 Covid + PCR test- asymptomatic, was tested prior to surgery 4/17 potential to return to work
I don't know if this is related to the vaccine. There is a white coating on the mucus membrane inside the nose for about an inch inside each nostril. You can't wipe it away, it is in the tissue of the mucus membrane.
This case was reported by another manufacturer and described the occurrence of not responding to therapy in a subject of unspecicifed age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). In 1999 the subject received unspecified dose of Havrix (unknown). At an unspecified time after vaccination with Havrix, the subject experienced not responding to therapy. At the time of reporting the outcome of the event was unspecified.
Elevated temp 100.4 loss of consciousness next day. Swelling, redness inj site with bruising.
Hsp/ purpura. Started on one thigh around injection and spread down leg, both buttocks, other leg over course of 1 month. Also had swelling of both feet, both hands, joint pain and fever.
Patient received Janssen COVID vaccine on 5/3/21. On 2/7/22, patient's COVID status was positive. On 2/19/22, patient admitted to our inpatient facility with ARF on CDK3 of kidney transplant, acute pancreatitis, and COVID19 infection (no SOB/hypoxia, viral changes in lower lungs on abd CT scan).  As of today (2/21/22), patient is still admitted in the med/surg unit.
administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient who was administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2022, the patient received a 0.5 ml only the liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) (lot U7311AA, exp date: 09-Sep-2023) via intramuscular route in the left thigh as Immunization.  On 29-Aug-2022 (latency: same day), the patient developed a non-serious event of "administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) with no reported adverse event (single component of a two-component product administered" (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the guidelines. 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.
Was given shots when not required and up to date. Received extra dose of MMR-V, Dtap, HIB, PCV. No illness event post immunizations.
left arm pit is swollen; left arm pit is hurting; This is a spontaneous report from a contactable consumer (patient's wife). A 47-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Jul2021 15:50 at age of 47-year-old as dose 1, single dose for covid-19 immunisation. The patient had no medical history and no family medical history relevant to event. The patient's concomitant medications were reported as none not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient on the day before reporting, on 22Jul2021 began having a swollen and painful area in the left armpit. The patient did not go to physician office or emergency room due to these events. The patient did not do any investigation. The reporter stated that it was staying about the same and wanted like to know if this was a common side effect with the vaccine and if it would go away. The reporter asked if the patient should get the second dose of the vaccine after having this side effect with the first dose. The outcome of the events was not recovered.
Nausea, vomiting, diarrhea, weakness, dizziness, cramps
Rabies immunization given 2/15/09 (Booster). States no pain on 2/15/09. States in afternoon on 2/16/09 had dull headache which lasted one hour. On 2/17/09 about 9am developed dull headache which lasted 20-30 min. During screening for plasma donation about 10:45 on 2/17/09 donor reported the headaches. Stated took no medication for headaches.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Whenever I move my head I get very dizzy. I had a very negative response to the second Moderna shot and ran a fever and was unable to get out of bed the next day. This continued for about 24 hours. I am still experiencing intervals of dissiness to this day. I have been taking over the counter motion pill to alleviate the problem. They help somewhat.
C/o abdominal discomfort approximately 2 hrs after administration of hep B vaccine. Follow up received: 1. Date of birtth; 2. Age 23; 3. Adverse event onset date 6/10/10 at 1400 (given) reaction at 1630 6/10/10; 4. Did not require hospitalization or visit to her doctor; 5. Given 6/10/10 at 1400
1st dose  06Nov2018, 2nd 17aug2022; This case was reported by a pharmacist via interactive digital media and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th November 2018).   On 17th August 2022, the patient received the 2nd dose of Shingrix. On 17th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The pharmacist reported this case via interactive digital media. The patient received her first dose on 6th November 2018 but never got her second dose. The pharmacist gave the Shingrix shot to the patient on the day of reporting. The reporter asked what should be done after today's (day of reporting) dose or whether she should get another dose in 2-6 months. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
High temperature 100-101 degrees F. Rash maculopapular. Full recovery in one week.
Hives on the face, neck, arms, legs and torso accompanied by itching. Went to bed the night of 10/12/2013 and had itching during the night. Woke in the morning to find her body covered in hives. Was given a topical ointment for itching. The hives began to go away on Monday 10/14/2013 with the itching becoming less frequent.
ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
reported feeling "lightheaded" 20 mins post vaccination.  h/o "anxiety with needles & injections previously by report.  Denies any other symptoms - no resp difficulty .  lungs clear.   TX- mask removal; fresh air flow; emotional support 7 car seat reclined.  additional wait time - left lot with spouse driving vehicle.
Patient experienced excrutiating pain in the right arm after receiving the flu shot. They were unable to raise their arm even after a month since receiving the shot. Patient is currently still seeking medical help.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown dates, the patient was vaccinated with all the 3 doses of RECOMBIVAX HB (dosing details, lot# and expiry date were not reported) but the patient did not seroconvert. On an unknown date, titers were done but the result was unknown. No treatment was given for the event. The patient did not seek any medical attention. The outcome of 'did not seroconvert' was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
According to parents; Pt had 2 1/2 - 3hr period of inconsolable screaming which thereafter resolved w/out sequelae; Also the inject site was reddened & swollen for 1-2 days;
Headache, Myalgia, Soreness at injection site Narrative: Per nursing report: "received COVID injection @1030 am on 1/27/21 and is now experiencing Flu-like symptoms, arm pain and headache"
upper arm was itchy at the site of injection; red,the size of a large coin; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) and INJECTION SITE ERYTHEMA (red,the size of a large coin) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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 19-Feb-2021, the patient experienced INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) and INJECTION SITE ERYTHEMA (red,the size of a large coin). On 23-Feb-2021, INJECTION SITE ERYTHEMA (red,the size of a large coin) had resolved. At the time of the report, INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) outcome was unknown.        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.
Patient tested positive for COVID-19 9/23/2021. Hospitilized 9/23/2021. Patient was fully vaccinated 2/26/21 and 04/03/2021 with Moderna. Paitnet expired 10/02/2021
About 3 weeks after getting vaccine on 5-20-2022, started having heart palpitations.  This was a new condition.
This spontaneous report was received from a nurse practitioner refers to a 46 years old patient who on 04-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Systemic: Patient reported feeling changes in mental status, delirious, couldn't use words properly, confused, euphoric-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Altered mental status lasted about a day and a half, now that mental status changes have resolved. Patient is numb in right leg. Cannot feel skin on leg only deep pressure if poked very hard. Normal movement and use of limb.
paresthesias-legs got hard & muscles stiff 5 days p/flu shot cont to have trouble walking;
Itching; Redness; Large welts; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 60 year-old female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus, erythema and welts. On an unknown date, the outcome of the pruritus, erythema and welts were recovered/resolved.   It was unknown if the reporter considered the pruritus, erythema and welts to be related to Shingrix.  Additional details were reported as follows: Pharmacist called in to report patient experienced large welts, redness and itching that lasted for 3 weeks after first dose of Shingrix.   Pharmacist stated patient has a lot of reactions to a lot of vaccines and was thinking about postponing until COVID-19 calmed down. Did not consent to follow-up.
Case number PHEH2014US021079 is an initial spontaneous report from the nurse received on 18 Oct 2014. This report refers to an adult patient of an unknown gender. It was reported that the patient was inadvertently vaccinated with two doses of FLUCELVAX (batch number: 013611A) intramuscularly on 17 Oct 2014. No adverse event reported following this medication error.
I had tinnitus after each time I took the vaccine. I also had swelling under my arm/lymph nodes after the 2nd vaccine lot number ER8729 and booster 039f21a
pt recv vax & to lobby syncopal-brief tonic/clonic sz x 30sec;
My adverse event started on 09/14/2022 at 10:30PM. I went into Arterial Fibrillation. My heart rate went up to 175 beats per hour. I had chest pains. I went to the ER where they performed all kinds of tests but nothing showed. They performed  Cardioversion on me and released me the same day. It reoccurred again on 12/30/2022, I went to the ER and again they did cardioversion. It happened again on 03/13,2023, and 03/20/2023. I will be going to the local clinic tomorrow 04/13/2023 and 04/14/2023 so they can study me and rule out the cause of AFIB.
Patient came into pharmacy with red non-blister rashes on her skin all over her body. She stated they were very itchy.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Cellulitus-Medium, Additional Details: Patient has swollen, red, hot to touch immunization site one week later.   reported a fever.   Minute clinic practicioner was able to see patient and diagnosised with cellulitus post vaccine
pt recv vax 17JUL97 145PM & pt returned to clinic 210PM w/rash on BUE;VS t98.2, P82, R20, BP 120/80 WNL:pt offered DPH;no SOB or dizziness;pt refused medical attention;
I was diagnosed with a Pulmonary Embolism on Jan 7 2023.  Between the booster and the PE, I contracted a bad case of Norovirus and flew home when well enough (likely dehydrated.)
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.