chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart inflammation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Heart inflammation) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Cardiac arrest and heart inflammation. Concomitant medication was not reported. Patient's autopsy result showed cardiac arrest from heart inflammation. Treatment details were not reported. Cardiac arrest was reported symptoms of Heart inflammation. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This spontaneous case concerns a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (fatal) adverse event of special interest Carditis (Heart inflammation) on an unknown date in the context of having received a dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and event onset were undisclosed. Treatment and laboratory details were not reported. The event led to a fatal outcome on an unknown date. It was reported that  autopsy result showed cardiac arrest and heart inflammation as the cause of death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (fatal) adverse event of special interest Carditis (Heart inflammation) on an unknown date in the context of having received a dose of mRNA-1273 vaccine. Onset latency could not be determined as dates of vaccination and event onset were undisclosed. Treatment and laboratory details were not reported. The event led to a fatal outcome on an unknown date. It was reported that autopsy result showed cardiac arrest and heart inflammation as the cause of death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Autopsy-determined Cause(s) of Death: Cardiac arrest; Heart inflammation.
On 4/15/01, pt had a brief (10-15 second) tonic/clonic generalized seizures (3 in 1 hr) at 20:00, followed by 5 of slighter duration in the next 2 hours. Had none after phenobarbital. No fever at any time.
1st dose 04Oct2022, 2nd 17Oct2022; 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 10-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 737X2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 17th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2022 Reporters comment: The reporter was a medical assistant. The patient's first Flulaval dose was on 4th October 2022. The reporter reported that they inadvertently administered an early dose of Flulaval vaccine to a patient in their facility. The reporter did not consent to follow-up. Additional Supportive information: The patient received second dose of Flulaval vaccine early than recommended interval, which led to shortening of vaccinations schedule.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in the refrigerator on 18-Nov-2021.Vial did not undergo any temperature excursion.  No adverse event was reported. No treatment medications were reported.
Lose of Appetite,  Weakness, no desire to do anything for about 24 hrs.
Minor back pain on the morning of the 18th. Rash at injection site and abdominal pain on the afternoon of the 19th.   By midnight on the 19th a severe migraine that necessitated 2 ER trips as pain meds given AFTER 2 hours in the ER with fluids, anti nausea and IV Dilaudid worked until the drug wore off.   Oxycontin for pain control after was ineffective.   After the migraine passed (three days later) I am still left with minor flu like symptoms and remaining back pain.  It has been 8 days since the vaccine and I am still suffering ill effects.
Vaccination site induration; itchy arm/ developed an itchy arm around the injection site; a large red induration around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site) 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 Heart attack in January 2021.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration). 24-May-2021, the patient experienced VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site). At the time of the report, VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received contains no new information. On 23-Jul-2021: Follow-up information received contains no new information.
patient reports soreness in arm and hurting to lift arm up. patient reports seeing her ortho PA on November 12, 2019 and received a Cortisone injection. patient reports seeing Ortho on 1-22-2020 and received prednisone dose pack. patient reports seeing ortho on 2-27-2020 to schedule a MRI.
pt recv vax 9OCT97 & triceps muscle area became sore by 12OCT97 lt arm seemed to became weak;lt arm w/marked avoidance of lifting;
This spontaneous report as received from a nurse refers to a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date approximately in 2015 (also reported as a few weeks ago) the patient was vaccinated with GARDASIL dose 1, intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date approximately in 2015 (also reported as the day after receiving the vaccine ) the patient experienced nausea and broke out into hives (urticaria). It was reported that the patient sought medical attention and called the physician. The patient was directed to an unspecified dermatologist. It was reported that the therapy with GARDASIL was discontinued and not reintroduced. The outcome of nausea and urticaria was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. Additional information has been requested.
pt stated her middle finger was tingly/numb then by time she left she said it had eased up
Information has been received from a patient who on an unspecified date was vaccinated with a dose of MMR II. On approximately 21-APR-2010, the patient had negative titers to measles. At the time of the report, the patients outcome was unknown. No further information is available.
given vax & passed out 3mins later; No sz activity but initially difficult to get pulse & no breathing (for about 30-60 sec);
had all kinds of infection with head and lung; had all kinds of infection with head and lung; always running a low grade fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 27Jan2021 13:30 (Batch/Lot Number: FC3181) (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was pharmacy/drug store. The patient medical history included COPD. It was reported that before receiving the vaccine, she was misdiagnosed with a brain disorder and Myasthenia Gravis (as reported), and she was taking medications for it. Prior to any Covid 19 vaccines she was diagnosed with a brain disorder and she was in bad shape at that time and they brought her to the emergency room. She had pain in her abdomen, a CT scan was done and she was in the emergency room for over 8 hours. She had also been transferred with the ambulance because they thought she was going to have massive respiratory failure. She was taking medication for those conditions. The medication to treat the conditions (unspecified) were also prior to any vaccines and she no longer takes it, had been on it since Oct2018 and last took it Oct2020. This was all when she was misdiagnosed and given pyridostigmine. Came to find out that this medicine was killing her and she was misdiagnosed. She had some bloodwork done (unknown results) because they were trying to track down her thyroid and that was done at the hospital. There were no concomitant medications. No previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. On an unspecified date, the patient experienced had all kinds of infection with head and lung and always running a low grade fever. Serious stuff was going on before her second dose of the Pfizer COVID-19 vaccine. The outcome of the events was unknown.
Fatigue; Vaccination site pain; Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp) had not resolved.            No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2022: Followup document contain, the event of "psoriasis flare up" was amended to "Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp.
Severe eye inflammation whole sclera of my left eye turned red, seen ophthalmologist confirmed inflammation of the upper area of the sclera and prescribed steroid and take NSAIDS such as Aleve.
Received new intradermal flu vaccine at clinic for the first time. Went to private doctor after the second day.  Red raised and painful patch from mid arm to elbow size of grapefruit. Arthus Reaction. I have had flu shots each year for past 7 years including H1N1 a few years ago.  Never had an intradermal flu vaccine before and never this bad a reaction.
Large visibly swollen area over left supraclavicular lymph nodes. 2 inches x 3 inches in diameter. Soft and palpable. No pain or other symptoms. For the first 3 days post vaccination, the injection site and upper arm muscle were sore. No redness. The initial soreness went away on the third day.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 23-OCT-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Patient reported feeling flushed and shaky after injection.  Episode was short lived.  After second episode it was decided to transport patient to ED for evaluation via wheelchair.  ED notes: patients states she felt very flushed, cheeks were flushed, very slight itchiness in her mouth and tongue and very slight nausea and very shaky.  Denied shortness of breath or chest pain.  Medications given: 1815 diphenhydramine 50mg IV 1820 methylprednisolone 125mg IV Normal saline bolus 1840 famotidine 20mg IV 1817 hydroxyzine hydrochloride 50mg IM 1841 epinephrine 0.3mg IM 1823
Pain under my left breast in the rib gage; This case was reported by a nurse via call center representative and described the occurrence of rib pain in a 79-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingles vaccine. On 12th March 2020, 20 days after receiving Shingles vaccine, the patient experienced rib pain. On an unknown date, the outcome of the rib pain was unknown.   The reporter considered the rib pain to be possibly related to Shingles vaccine.  Additional details were provided as follows: The patient had pain under their left breast in the rib gage. The patient was wondering if the shingle shot could be a cause?
PATIENT GOT THE VACCINE ON 10/14/22. HE SAID IT TURNED RED ABOUT 6 HOURS AFTER. ON 10/16/22, HE WOKE UP WITH FLUID FILLED BLISTERS (ALMOST LOOKED LIKE BLISTERS AFTER A BURN). HE ALSO COMPLAINED OF MASSIVE LYMPH NODE SWELLING, ITCHING, HEADACHE, NAUSEA, CONSTIPATION AND SHORTNESS OF BREATH. HE WENT TO HIS DERMATOLOGIST, ON 10/18/22 WHO SUSPECTED AN ALLERGIC REACTION TO SOMETHING IN THE BIVALENT FORMULA AND PRESCRIBED HIM PREDNISONE STEROID FOR 5 DAYS
Information has been received regarding a case in litigation from a consumer, concerning her son who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (lot number, injection site and route not reported). Subsequently the patient became autistic. It was unknown if the patient sought any medical attention. The patient's event persisted. Upon internal review, became autistic was considered to be an other important medical event. No further information is available.
pt recvd HIB/MMR @ 10AM p/MD exam in which no abnormality found 1DEC92; t95 ax; mom called 8AM 2DEC92 to report febrile convuls; 1DEC92 given APAP @ 730PM sz approx 1 min; taken to ER t102.7;
Client was administer 2nd dose of Moderna COVID-19 vaccine at 1:32pm.  Client reported has "sore arm from first dose", but denied any other issues from 1st dose.  At 1:44pm, client reported was feeling flushed and slightly dizzy/light headed.  Client appeared flushed, clammy and was slightly confused.  Client was sitting in chair and was assisted to the floor and clinical assist code was called.  VS were: BP: 149/84 and pulse ox was 97% on RA.  Initially, HR was in the low 30's, but after lying down, came up to 86 and stayed in the 80-90's during assist.  Client began to report chest tightness and feeling foggy and remained slightly confused and at times speech was garbled.  Client denies sensation of throat closing and denied shortness of breath.  Client was assisted to a cot and transported by ER staff and MD to the ER for evaluation.
Red raised rash on left deltoid that appeared 7 days after vaccination. Benadryl cream and ibuprofen. Instructed patient to seek medical care if rash worsens or symptoms change.
Dad notified redness on left arm where DTaP and IPV were given - 2 days after it was given. Afebrile.
Four days after vaccine daily headaches started.  14 days after vaccine pins and needles sensation began on feet, legs, arms, hands and back.  I am now 22 days post vaccine and all symptoms are continuing.
On 11/10/02, pt woke to find right arm red from the elbow to the shoulder. Arm was swollen and felt heavy-at date of inspection on11/21/02. Arm was swollen (Severely bruised between shoulder and elbow.)
APRN administered the above vaccines to the patient on 8/9/23. Patient left clinic without side effects or reactions. APRN realized later that evening that she had inadvertently given the pediatric 0.5 mL dose of Engerix Hep B rather than 1.0 mL adult dose.
Client c/o pain in lt arm, limited mobility, lasting 3 wks length was seen by MD;
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced shingles. No other information was provided. Additional information has been requested.
As pt was leaving the facility after observation, pt was nauseous & dizzy & kneeled on the floor. BP 111/59; HR 70; RR 18. Pt was deemed stable & released from vaccination site.
p/3rd dose of vax devel erythema, swelling over eyes in 3 specific areas; eyes very swollen; given 4th dose w/no exacerbation; Bitten on the forearm by ferrel cat which was not caught;
Admitted to hospital for severe thrombocytopenia with bleeding, covid positive on 12/28/21.
Severe pain, extreme swelling, hives, redness in arm, armpit,  and left breast.  Pain continued to increase over night.  I applied cold compresses, and took Motrin and Benadryl.  The pain was so intense that I was in tears.  It would not stop.  The pain went down my arm to my hand as well.  I was unable to sleep.  The swelling has gone down, but is still present.  There is discoloration under the bottom of my upper arm, arm pit and breast.  The pain is still awful when my arm is not in use, and  increases when I do use the arm.  I reached out to doctor's office and for two weeks I didn't receive a call back from anyone at the facility following almost two weeks of calling.
Within about a year after getting  the  Tdap (Boostrix) vaccine, I got strabismus in the left eye which caused double vision , I am wearing  bifocals to correct  the problem.
tremor on her index finger; pain on below her elbow; generalized body aches; Right Arm Pain; increase in her blood pressure 194/128; heart rate of 138; bad migraine on the right side of her head; A report was received from a consumer on 03 JAN 2021 concerning a female patient who experienced an increased blood pressure and heart rate, headache, right arm pain, body aches, and finger tremors after receiving the Moderna COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were provided.   The patient received her first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) on 28 DEC 2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On the same day, about 15 minutes later, the patient reported to have developed a blood pressure of 194/128 mmHg, and a heart rate of 138 beats/minute, along with a right-sided headache. The increased blood pressure and increased heart rate were reported to have resolved 15 minutes later (repeat blood pressure and heart rate values were not provided). On 29 DEC 2020, the patient experienced pain in the right arm along with generalized body aches. She expressed that she developed tremors in her index finger on 02 JAN 2021. There is no information regarding the intensity of her pains, or how long each of the event had lasted before resolving.  No interventions or treatment information was provided for the events.  The outcome of all events was reported as recovered/resolved on the same day that they occurred. There is no report regarding a reoccurrence. Any action taken regarding the vaccine as a result of the events is not applicable.  Reporter causality for the events was not provided.  The patient provided consent to follow-up with Safety.; Reporter's Comments: 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.