chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, pain and red rash at the injection site. Felt achy, tired and had a headache for a day.
Due to a scheduling error, patient was administered her second dose prematurely. (2 weeks 5 days after first dose).
Redness, swelling and soreness at injection site, chills, body aches everywhere, tinnitus worse
pt recv vax 10MAR97 & next visit 5MAY97 parent said pt cried inconsolably for 2-3hr about 36hr p/vax;leg not red, swollen or sore;no fever, family would have brought pt to ER for the crying spell but they were out of town;
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the RA at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the RA was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the RA. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
He began with a high fever the first day. Within that week he started having flu like symptoms, severe body aches, fever but no sinus activity. This continued for a month. After several pediatrician visits, xrays and two blood work ups we were directed to Hospital, Infectious Disease Department. More blood work, xrays and scans revealed what they believe to be Polyarteritis Nodosa, a vasculitis disease. He was perfectly healthy the day of his yearly checkup.
Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020).  After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain.  Within 12 hours, I experienced diffuse myalgias.  After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours).  There was significant fatigue the first 36 hours after the second vaccine administration.  I took two doses of Tylenol on the first day.  No rash.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 medications were mentioned. Treatment medications were not reported
Sore Arm started and now there is alot of pain and hard to move my arm certain ways.  I feel like I have lost strength in the arm and it wakes me up 3 to 4 times a night.
Patient received the Pfizer Covid 19 vaccine. She was hesitant to receive it because she said she had an adverse reaction to flu vaccine. She had an anaphylactic reaction in the past. She is also prone to allergic reactions to various antibiotics. She said she was only getting the vaccine because of the state mandate. She received her vaccine at around 1:20 pm and almost immediately had an allergic reaction. She said her throat was swelling up and she had a hard time breathing. Code white was called. Offered Epi-pen, but the patient already had one and she said she did not want to inject it because that would mean a trip to the hospital. Her husband was a paramedic and he had the epi-pen handy in case she stopped breathing. She insisted on benadryl. She was given 6 capsules of benadryl. Patient insisted on taking 6 capsules. She has had similar reactions and she said she always takes 6 capsules. After a few minutes, patient insisted on going home. She left with her husband.
dental issues for a couple of months now; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (dental issues for a couple of months now) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 TOOTH DISORDER (dental issues for a couple of months now). At the time of the report, TOOTH DISORDER (dental issues for a couple of months now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was getting the second dose of Moderna on Monday. The patient reported to have a tooth fill later and needs to take antibiotics. Concomitant and treatment medication information was not reported.  information was not reported
Small balls in neck; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (Small balls in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK MASS (Small balls in neck). At the time of the report, NECK MASS (Small balls in neck) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
This spontaneous report as received from a registered nurse refers to a patient (age range reported as 14, units not reported) of unknown gender. On 06-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number and route were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Patient had COVID vaccine on 3/12/21(Janssen), and is hospitalized now (admitted 9/26/21) with acute hypoxic rerspiratory failure secondary to COVID pneumonia (expected D/C is not for 3 or 4 more days)
This spontaneous report was received from a register nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received dose of RECOMBIVAX HB (strength, dosage, route, lot# and expiration date were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
As soon as vaccine was given patient reported increase in heart rate told her to relax and elevate her feet  after few minutes i asked to if she would like me to call 911 which I did.  Using pulse ox meter checked her pulse it was 118 when we started got it down to 84 but it went back up all the way to 160 EMT arrived and assessed her and took her to Emergency Room. Patient never lost consciousness
On 02/18/2023 in the evening, I had early head cold symptoms. I was stuffy. The next morning, I knew it was coming. My nose was running and I was sneezing. The next day, it was no better and I decided to test for COVID-19. I tested positive. I had fatigue. I called my doctor's office. They wanted to put me on PAXLOVID, which I did. Cold symptoms and fatigue stayed, and then subsided. I am better now. I tested again 03/05/2023 and tested negative.
I receive a flu shot every year without incident.  This year, It seemed painful upon administration (larger, longer needle perhaps).  My arm and shoulder remained sore until present, as well as pain in the axillae of the immunized arm that developed the next day.  4 days post vaccination and the shoulder/armpit pain still remains with some swelling of the armpit.
Dizziness, Headache, Fever, chills Narrative:  Other Relevant History:
little fever; chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 1, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced a little fever and chills. Patient received treatment with Tylenol and it went away. It was reported that the patient could take blood test, from which he could know if it was working or if it was building immunity. Patient underwent lab test and procedure which included blood test: unknown result, on an unspecified date.The clinical outcome of both the events was resolved on unspecified dates in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician via a company representative refers to a 50 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, dose and route not reported) for vaccination. On an unknown date, the patient experienced urticarial vasculitis after vaccination. The outcome of the adverse event was unknown. It was not reported if the patient had sought medical attention. Additional information has been requested.
Mother called: states daughter complaining of left arm swollen and painful. Asked to stop at Health Dept so we could view and assess arm. Client did not comply.
Pt developed rash on RUE where imm was given and a fever of 102.6.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022, they were put on hold by the local Health Authority at the moment and could not administer the Moderna COVID-19 vaccine to patients until an assessment by the local Health Authority was made. There were power outages that would have impacted the Moderna vaccine. However, she reiterated that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. No adverse event reported.
Case number PHEH2015US022656, is an initial spontaneous report from a health care professional received on 03 Nov 2015. This report refers to a 42 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) incorrectly at a dose of 0.1 ml intradermal on an unknown date. On 02 Nov 2015 the patient experienced redness, swelling and itching at the injection site. Events stop date was reported as 02 Nov 2015. Final outcome of the events were not reported. Seriousness and causality of the events were not reported.
Approximately 2 weeks after 2nd dose: 1. increased arthritic pain, new ankle swelling pain - needed to use an air cast and ultimately diagnosed as Posterior tibial tendonitis on 6/3/2021  2. muscles so stiff in AM that it was hard to straighten legs -On 3-12-2021 Discussed with Dr. Infectious Dis specialist - treated with new anti-inflammatory herbs and herbs that stabilize mast cells -    ? Quercetin 400 mg BID, ginger root 500 mg bid       ? cucumin as Meriva 500-SF (Soy Free)  1 BID  Dr. added low dose naltrexone now at 3 mg/d. 3. loss of control of blood pressure - 130/80 to 180/90 - increased lisinopril from 10 mg/d to 20 mg/day
8/5/03 PM c/o L arm soreness 8/6/03 PM c/o H/A and L sore arm increased. 8/7/03 AM and PM c/o intermittent H/A, increased L shoulder pain at upper edge of scapula, muscle pain in neck L side, 8/8/03 c/o bilateral temporal pain when asked to place chin to chest. Referred to ER or urgent care for MD evaluation. Observations: L upper arm red swollen and hot to touch, area red 9mm x 13mm, scapula area red 2mm x 3mm. Called on 8/12/03 Ct. working recovered.
Feeling generally bad; Arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling generally bad) and PAIN IN EXTREMITY (Arm hurting) in a 39-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling generally bad) and PAIN IN EXTREMITY (Arm hurting). At the time of the report, FEELING ABNORMAL (Feeling generally bad) and PAIN IN EXTREMITY (Arm hurting) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.
BEFORE VACCINE ADMINISTRATION, PATIENT STATED THAT HE HAS A PHOBIA TOWARDS RECEIVING SHOTS.   ALMOST IMMEDIATELY AFTER VACCINE, PATIENT REPORTING FEELING LIGHT-HEADED.  HE SAT DOWN IN A CHAIR FOR 5 MORE MINUTES.  ONE PATIENT TRIED TO GATHER HIMSELF AND WALK TO THE PHARMACY EXIT, HE PASSED OUT AND FELL FORWARD INTO THE ARMS OF THE PHARMACIST MANAGER AND VACCINATOR.   HE WAS AGAIN PROVIDED WITH A CHAIR, SOME WATER, AND A COLD TOWEL.  HE RECOVERED ABOUT 15 MINUTES LATER.
Temperature 100 - One day 3/28/2021 Nerve headache - grabbing pain from back of head to left side; grabbing pain from left side only - 3/28 & 3/29/21 Left arm - terrible pain in arm Body aches - particularly in both arms Extremely tired - slept all day and night from 3/27 afternoon thru Monday morning, 3/29
This subject is a 72 year old male who died while enrolled in the RSV11 study. Subject received RSV vaccine or Placebo and influenza vaccine on 10/15/2003. The subject developed shingles 10/19/03, 4 days post immunization and 7 days later, on 10/26/03 he had increasing shortness of breath and died while on the way to the hospital. The death was reported by the investigator as possibly related to the study vaccine.  Follow up on 12/10/03: "Additional info received 12/01/03.  Death cert received with the date of death being 10/28/03 not 10/26/03 as stated in the initial report . Cause of death was CHF w/approximate interval of 2 weeks between onset and death.  Due to or as a consequence of CAD w/appropriate interval of years between onset and death.  Due to or as a consequence of Idiopathic Pulmonary Fibrosis w/approximate interval of months between onset and death." Follow up on 02/09/04: "The causality has been changed by the investigator from possible relationship to "unrelated"."
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Local reaction with 2.5cm area of erythema, edema, increased warmth, and localized itching.  Patient did not have difficulty breathing, wheezing, nausea or vomiting.
Patient got dizzy and was about to faint. Provide Gatorade drink, advise patient to place head between legs  to help with circulation. Provide water, spirit and bag chips. Continuous blood pressure monitoring. Patient felt fine with 30 min and able to go home.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 15-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Child came into office on 2/6/03 and diagnosed w/a mild case of atypical varicella. Support care only for symptoms.
Pt. got pregnant 2 mos. after 2nd GARDASIL injection.  Last inj. 11/30/07 / LMP 1/1/08 - preg. mid Jan. 2008
This spontaneous report was received via social media from a consumer and refers to a female patient of unknown age. The patient's concurrent condition included a viral infection (reported as "dormant virus similar to Lyme disease"). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced progression of the viral infection (reported as "the vaccine actually woke it up"). Action taken with the therapy, the outcome of the event and the relatedness between the event and the GARDASIL were not reported. Additional information is not expected as no contact details were provided.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider on admission: "Pt is an 82 yo female with pmhx CAD s/p PCI and CABG, bradycardia, CKD,  HTN, SS, CVA, thyroid disease being admitted with elevated BP. She was diagnosed with COVID 2 weeks ago.    In the ER she was noted to have gait ataxia and ataxia of the LLE.    The pt states that she has had elevated BP at home, 190/89 and has had a pounding throbbing headache for 2-3 days. Denies CP or vision changes. Admits some mild dizziness and unsteadiness. No focal weakness but feels generally weak since COVID. No falls. No facial droop, speech changes but does admits some tingling when she feels dizzy which is "all over," nonfocal.    She has been taking her blood pressure medications at home. She has had severely elevated BP in the past associated with anxiety. She takes xanax at home. Worse when arguing with sister.   She developed COVID two weeks ago with coughing, sneezing, runny, mild SOB with coughing. Most of those symptoms have resolved except for cough. She is vaccinated against COVID.    Patient denies  shortness of breath, abdominal pain, nausea vomiting diarrhea constipation, swelling, rash, fevers.  "