chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Respiratory failure; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: (Privacy)    The patient's past medical history included Liver transplant.  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 RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and COVID-19 (COVID-19). The patient died on an unknown date. The reported cause of death was Respiratory failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 (COVID-19) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RESPIRATORY FAILURE (Respiratory failure) and COVID-19 (COVID-19) to be related.    Concomitant medications were not reported.  Treatment details were not provided.  Patient developed COVID-19, 18 days after the second dose of mRNA-1273 vaccine and died from respiratory failure.  Company Comment: This is a literature case concerning an 80-year-old male patient with medical history of liver transplant, who experienced the non-serious unexpected AESI of COVID-19 and serious unexpected fatal event of respiratory failure. The events occurred 18 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 was not applicable to the product administration and conservatively assessed as related for respiratory failure event. Very limited information available on the disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   This case was linked to MOD-2022-469634 (Patient Link).; Sender's Comments: This is a literature case concerning an 80-year-old male patient with medical history of liver transplant, who experienced the non-serious unexpected AESI of COVID-19 and serious unexpected fatal event of respiratory failure. The events occurred 18 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 was not applicable to the product administration and conservatively assessed as related for respiratory failure event. Very limited information available on the disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.; Reported Cause(s) of Death: Respiratory failure
Knot like an egg on the elbow; A spontaneous report was received from a consumer concerning a 38-year old, male patient who experienced knot like an egg on the elbow.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 23 DEC 2020, the patient received one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) by injection in the right arm for prophylaxis of COVID-19 infection.   On 24 DEC 2020, the patient developed a knot like an egg on his elbow in the left arm. The knot felt liquid inside and did not hurt. Treatment for the event included diphenhydramine HCl.   Action taken with mRNA-1273 in response to the event was not reported.   The event knot like an egg on the elbow was considered not recovered/not resolved.  The reporter did not provide an assessment for the knot like an egg on the elbow.; Reporter's Comments: This case concerns a 38-year-old, male patient. The patient's medical history was not provided. The patient experienced an unexpected event of swelling on elbow. The event occurred 1 day after one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sudden onset arthralgias 12/29/08.  Pain, swelling elbows, wrists, hands, fingers,knees, ankles low grade temp initially.  Seen by PCP & Rheumatologist.  PREDNISONE.
Pain in left arm with redness and swelling. Given 25mg BENADRYL by mouth.
7/8/2023 Soreness at injection site Headache Nausea Fever
thirsty; not hungry; sore arm; tiredness (slept alot); headache; light fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirsty), DECREASED APPETITE (not hungry), LIMB DISCOMFORT (sore arm), FATIGUE (tiredness (slept alot)) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THIRST (thirsty), DECREASED APPETITE (not hungry), LIMB DISCOMFORT (sore arm), FATIGUE (tiredness (slept alot)), HEADACHE (headache), PYREXIA (light fever) and CHILLS (chills). At the time of the report, THIRST (thirsty), DECREASED APPETITE (not hungry), LIMB DISCOMFORT (sore arm), FATIGUE (tiredness (slept alot)), HEADACHE (headache), PYREXIA (light fever) and CHILLS (chills) had resolved.            No concomitant medications were reported by the reporter.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-073059 and MOD-2021-124783, MOD-2021-073059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Followup information was received on 16-Jun-2021 and contains non-significant information. The contact detail was added.
bad headache; sleepless; chills; bedredden; Social problem; This case was reported by a consumer and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced headache, sleeplessness, chills, bedridden and social problem. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, sleeplessness, chills, bedridden and social problem were unknown.   It was unknown if the reporter considered the headache, sleeplessness, chills and bedridden to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had no special health issues The patient experienced bad reaction after the first dose for one and a half days in bed sleepless, bad headache, chills, etc. The Tylenol helped a bit. Due to the pandemic and high risk family members, the patient had been staying home as much as possible to reduce the risk of Covid 19, which led to social problem.   The patient had delayed going in to my local pharmacy to get the second shot.  The patient called them two days ago, they have a supply, but when the patient went in today they said the at the CDC is advising against vaccines due to various Covid 19 issues. The patient asked what was the consequence of getting the second dose after the six month date. If I or the pharmacy has eased restrictions in say 1, 2, or 3 months from now, would the 2nd dose be ok then.
196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein age group and I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:master case
sore arm headache weakness dizziness mental confusion loss of memory  All started morning of 3-6-21 except altered mental state which started around 2 pm on 3-6-21. The confusion lasted all night. Other effects are better but still present especially the weakness.
27-year-old male with history of hypertension and mood disorder was brought to the hospital by the cops since he was noted to have paranoid thoughts, hallucinations, homicidal ideations and aggressive behavior.  The police found him yelling on the streets and fighting.  Per notes, patient told that someone stole his father's car business and he wanted to kill him.  He also endorsed suicidal thoughts per notes.  He denies any history of suicidal attempts.  He has had 2 previous inpatient psychiatric admissions.  He drinks alcohol socially.  He denies drug use.  He uses cannabis recreationally.  He is currently homeless and collecting SSI.  He was seen in the emergency room.  His home medications were restarted. Additional information for Item 18: He was kept on Ativan, Haldol and Thorazine for agitation.  He was certified by the psychiatrist.  Currently awaiting placement.  Incidentally, patient was noted to have swabbed positive for COVID-19.  He is currently admitted as psych facility will not take him till he is off COVID precautions.  He does not have any upper respiratory symptoms at this time.  No fevers or chills.  No chest pain or shortness of breath.  He mentions to have received 2 doses of the vaccine in 2021.  When I examined the patient, he did not want to go into details of why he was having homicidal and suicidal ideations. Pt medically cleared for discharged to Inpt Psych with Behavioral Center, with EMS transportation. Healtchare coordinated and arranged by Inpt psych. No other needs.
Went into atrial fibrilliation again 10 days after 2nd covid booster. First event of A-fib followed a mildly symptomatic covid infection lasting 3 days. Sudden onset, no history of hypertension or arrythmias. Workup for initial even was normal (Echo, nuclear stress test, Holter monitor, blood work). Cardiologist told me he considered this an adverse event from the vaccine. Put on flecainide 150mg q 12h and I converted to NSR in 3 days. Still on meds.
I experienced a fever of 100; Chills; Headache; Nausea; Sore arm; Fatigue; The nausea was bad enough to cause me to vomit a number of times.; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration, administered in the left arm on 07Apr2021 at 11:00 as DOSE 2, SINGLE for COVID-19 immunization (at the age of 62-years-old). The patient's medical history was none. The patient was very healthy. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 at 11:00 as DOSE 1, SINGLE for COVID-19 immunization and the patient experienced sore arm. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 23:00, about 12 hours after receiving second dose, the patient experienced a fever of 100°, chills, headache, nausea, sore arm, fatigue and vomiting. This lasted for about 36 hours. It was bad enough to keep the patient in bed the whole while. The nausea was bad enough to cause the patient to vomit a number of times. The events did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures was taken for the events. The patient underwent lab test and procedures which reported as body temperature at 100° on 07Apr2021. The clinical outcome for the events was reported as recovered on 09Apr2021 at 11:00.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 22-FEB-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
A few minutes after taking had a ?cleaning? taste in mouth and tingling of tongue but no swelling of tongue. then for 15 mins off and on taste of metal/ soap. then after 15 mins never had again.  that evening had sore arm which intensified the next day tender to touch but by monday was better. also had a headache saturday.
arm hurt; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.     This case was linked to MOD-2021-090479 (Patient Link).
The pt developed red, swollen, burning (itching) area on left thigh. Treated with cool compresses and Benadryl.
About a week after the injection the injection site had a red rash around it that was very warm, itchy and painful to touch. Upper arm is swollen and hard. Resolved after 4 days. On 3-5 developed pain in the upper arm which radiated to lower arm and shoulder and lymph nodes in left armpit and left side of neck. This lasted about 24 hours.
Expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was given after expiration date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was 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 medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 18-Nov-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
Within 30 minutes of injection, feelings of muscle weakness and tiredness started. Shortly thereafter itching started around my mouth then proceeded to all extremities. This progressive itching continued for at least two hours until I took Diphenhydramine 25mg. I feel asleep for about 15 minutes and when I woke the itching was decreasing, and finally stopped. During the symptoms that were mentioned, I had a general feeling of being unwell, and considered treatment at a hospital. Since the Diphenhydramine was effective I did not seek hospital treatment.
no signs or symptoms reported, vaccine was accepted into Immprint, vaccine was given combined after recommended cut off age
8:45 child received vaccine and left clinic without complaints, mother stated child had seizure. To ER. Admitted to hospital. No further seizures noted. Temp ranged between normal and 103 x 3 days. Released from hospital 10/23/06, no lasting complications. 23 hour observation: Impression: Altered mental status-resolved Sickle cell anemia PMH: sickle cell anemia, acid reflux
nausea, headaches, dizziness, shortness of breath, throbbing, redness, swelling at injection site, trouble falling asleep
pt received expired vaccine dated 12/31/21 spoke with prfizer, Spoke with RN with Pfizer regarding pfiizer vaccine that was administered to pt on 1/3/22 per immunizations due to vial was expired as of 12/31/21. Per RN there is a 32 day max on vials that are refrigerated.  Medical information told nurse  to contact cdc to discuss 2nd step. Also contacted CDC and spoke with and recommended for pt to get re-vaccinated due to expired vaccine as soon as possible Pt has no c/o adverse effects at this time.
Patient presented to the ED and was subsequently hospitalized for Closed pelvic ring fracture within 6 weeks of receiving COVID vaccination.
Child presented with pain, fatigue, and noticeable enlarged, red, upper left arm.  Doctors observation states left arm very swollen, erythemic, and warm to the touch.  Doctors diagnosis states cellulitis (acute bacterial infection) treated with 10 day course of antibiotic (Augmentin) and allergic reaction treated with an antihistamine (Diphenhydramine)
Lump in arm for 3.5 weeks for me unexplainable rash for 4 weeks + for my 13 month old daughter
Patient fully vaccinated against Covid-19 and is deceased from covid related pneumonia illness. Patient died on 10/31/2021
passed away; This is a spontaneous report from a Regulatory Authority from a contactable consumer reported for a patient (friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization.  Medical history included staph infections. The patient's concomitant medications were not reported.  The patient had a couple staph infections before, received the Pfizer BioNTech COVID-19 Vaccine and 2 days later, had passed away. The patient died on an unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
PAIN, SWELLING OF LEFT ARM.  REFFERED TO URGENT CARE CENTER.
Patient reported large baseball size sore, hot and red area at the injection site. Patient reports significant swelling on Saturday. Patient has been taking ibuprofen and applying ice since then and the swelling has decreased. Area is still warm to the touch and red.
This is a 12 month old, spoke WITH MotheR on 3/26/2020. Toddler started with Rash - red flaT, NON-PRUITIC. He had been vaccinated on 3/18/2020 with MMR. No congestion, fever, Playful, good appetite. Told mother Reaction to MMR- Rash IS Self-lIMITINg. On 3/30/2020, video TeleVISIT. Rash was REd macular over body - No scratch marks. Mother states Rash is Resolving No other symptoms. Toddler is feeling WELL. Pt was diagnosed with BOM on 3/18/2020 finished amox on 3/28/2020. No hives.
Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as significant left axillary lymph node enlargement which both persist.
Patient came in to get an antibiotic and said she had gone to her doctor because her injection site was hot and red. It had started last night and got worse today. She said she got a steroid shot, doctor gave her KEFLEX and she bought BENADRYL to take.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Mild Asthma" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2022, stop date: 05Jun2022; IBUPROFEN, start date: 26May2022, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (May2022) Positive; (26May2022) Negative; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Tested negative and felt better after day 5 of treatment with Paxlovid (26May2022). Negative Covid test on 26May22. Cough and chills returned on 04Jun22 and tested positive on 05Jun22. Follow-up attempts are completed. No further information is expected.