chrisvoncsefalvay/vaers-outcomes huggingface dataset:
several hours(2-4) later went to bed not feeling well; weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (several hours(2-4) later went to bed not feeling well), ASTHENIA (weak), CHILLS (Chills), FATIGUE (Fatigue), DYSPNOEA (Labored Breathing), LOSS OF CONSCIOUSNESS (shortly lost consciousness) and DEATH (Died) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Lupus syndrome (lupus).    On 15-Dec-2021 at 4:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced MALAISE (several hours(2-4) later went to bed not feeling well) (seriousness criterion death), ASTHENIA (weak) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), DYSPNOEA (Labored Breathing) (seriousness criterion death), LOSS OF CONSCIOUSNESS (shortly lost consciousness) (seriousness criteria death and medically significant) and DEATH (Died) (seriousness criteria death and medically significant). The patient died on 15-Dec-2021. The reported cause of death was several hours (2-4) later went to bed not feeling well, weak, Chills, Fatigue, Labored breathing and shortly lost consciousness. It is unknown if an autopsy was performed.            No concomitant medication was provided by reporter. Patient shortly lost consciousness Paramedics called, Husband and Daughter applied CPR in the interim could not Resuscitate. No treatment drug was provided by reporter.; Sender's Comments: This case concerns a 75-year-old patient (gender not provided) with no relevant medical history, who experienced the unexpected events of Malaise, Asthenia, Chills, Fatigue, Dyspnea, Loss of Consciousness. The events occurred several hours after the booster dose of mRNA-1273 (Moderna Covid-19 vaccine); and resulted in death. The rechallenge was not applicable as events occurred after booster dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: several hours (2-4) later went to bed not feeling well; Weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died
hives were everywhere including her eyes and mouth; pressure on her right eye; jawline was swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4302776 (Genentech, Inc.).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "high cholesterol" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing), notes: underactive thyroid; "diabetes type 1" (unspecified if ongoing), notes: diabetes type 1; "hives" (unspecified if ongoing); "diabetic nerve pain" (unspecified if ongoing), notes: diabetic nerve pain; "anxiety" (unspecified if ongoing); "COVID" (unspecified if ongoing); "influenza A" (unspecified if ongoing); "pneumonia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; CARVEDILOL; PRAVASTATIN; AMLODIPINE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; PEPCID [FAMOTIDINE]; ALLEGRA; CYMBALTA; TRESIBA; NOVOLOG; FINASTERIDE; METOCLOPRAMIDE; MINOXIDIL; PREDNISONE; ASPIRIN [ACETYLSALICYLIC ACID]; CLOBETASOL; TRIAMCINOLONE; BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "recovered", described as "hives were everywhere including her eyes and mouth"; SWELLING FACE (non-serious) with onset Apr2021, outcome "recovered", described as "jawline was swollen"; OCULAR DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered", described as "pressure on her right eye".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer BV 12+  0.3 ml administered to a 10 year old.  Pt did not suffer adverse events other than localized reaction - pain at injection site.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-03-13.
Information has been received from a physician concerning a 72-year-old white, non-immunocompromised, healthy female who on 25-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (lot# 656385/0290U). "Two days later", reported as "26-JUL-2007" the injection site arm became very swollen and very red. The swelling was from the deltoid down the entire arm to the elbow. Medical treatment was sought, the patient was given antibiotics and the reaction dissipated. The outcome was recovered. No product quality complaint was involved. The reporter considered the patient's local swelling/inflammation and erythema to be other important medical events. Additional information has been requested.
pt recvd vax 1230-1PM 11OCT94 pt 20 mins ride home pt was unstable & falling (had had a nl exam in the office @ 1215-1230); came back to office & was definitely ataxic; sx improved over the next few hrs & completely resolved 18OCT94;
Patient behind on vaccines was reviewing his sisters vaccine to see how mom like to give the vaccines. I thought I was back in his chart and gave him MMR and Varicella and he wasn't due yet for them. Called health dept and informed them. Lady there said that he should be ok. May have fever in 2-3 wks but will need to be revaccinated. Mom called also.
Days before administration, I had a positive pregnancy test. Two weeks after administration, they found an anembryonic pregnancy. Since there are no studies on pregnant persons, I think it would be important to report this case in case it happened to other persons after administration, or for future studies.
loss of taste; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration in Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunisation. Patient received both doses, last being in Apr2021, and has had a loss of taste since. On an unspecified date the patient underwent lab tests and procedures several times which included Covid 19 tests: negative. The outcome of the event was unknown.
Nausea/severe night sweats/ fever /headache resolved over night with the exception of nausea
Moderna 1/27/21 and 2/22/21. Positive on 1/18/22.
itching; hot at the injection; rash; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness) in a female patient of an unknown age 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 PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
fell/tried to get up and fell again/he dropped/fell down; thirsty; did not feel any of his body parts/He was like twilight zone; can't drive; won't work for some days.; his legs gave out; bruised; Lost balance; injury in the shoulder; may be a fracture/breaks a bone; felt dizzy; the top of his shoulder is aching from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive) and IMPAIRED WORK ABILITY (won't work for some days.) in an 82-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.     The patient's past medical history included COVID-19 in October 2021.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall). At the time of the report, FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-425596 (Patient Link).
Soreness at injection site within 15 minutes of injection, moderate dry mouth within 3-4 hours of injection, head/neck muscle aches with 3-4 hours of injection
This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intramuscular). On 30th March 2019, several hours after receiving SHINGRIX, the patient experienced headache, nausea, chills and influenza-like symptoms. On 1st April 2019, the patient experienced injection site erythema and injection site rash. The patient was treated with ADVIL. On an unknown date, the outcome of the headache, nausea, chills and influenza-like symptoms were recovered/resolved and the outcome of the injection site erythema and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, influenza-like symptoms, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm in morning and experience headache, nausea chills and a little bit of the flu in the evening. Following Monday, the patient began to experience redness at the injection site, which measured at 3 inches x 2 inches. All events have resolved except for the redness, which is slightly improving after patient took ADVIL. The lot number was not available. The reporter did not consent to follow-up.
Approximately four hours after the vaccine was administered, my son gradually, over the course of maybe five to ten minutes, went from contemt and crawling around to screaming louder than I?ve ever heard a baby scream. In the midst of a high-pitched scream, he would  somehow suddenly burst into an even higher-pitched scream. He was swatting at his ears through the screaming episode as well. Nothing we tried could calm him, not even nursing, and we tried everything. After three or more hours we considered bringing him into the E.R. but after speaking with my husband chose not to for different reasons, and he finally cried himself to sleepafter three to four hours of high-pitched, inconsolable crying and screaming. He typically nursed a few times during the night at that point, but that night he slept until the morning. When he awoke, he seemed to be back to acting like himself for the most part.
Following the immunization I had mild discomfort in the lt. upper arm.  The discomfort increased in the next 2-3 weeks becoming more severe.  I was unable to sleep on my left side without pain in my shoulder area.  Six weeks after the vaccine my family doctor instructed me to use Motrin, ice and heat on the area for pain.  I seemed to be losing strength in my left arm and the pain persisted.  I was referred to an Occupational Health Center 10 weeks post vaccine and was told a vaccine would not cause this pain when no reddening, swelling, etc. were present.  No treatment was given.  I then saw a dermatologist who reported my persistent paresthetic discomfort at the injection site.  Now 5 months later my left arm is noticably weaker than the right arm and the deep constant pain has not been relieved.
Information has been received form a nurse concerning a 23 year old female who on 21-NOV-2008 was vaccinated injection with the first dose of GARDASIL (lot # not reported). After received the first dose of GARDASIL, on 22-NOV-2008 the patient's face was red and she had redness at the site of where the band aid was. The patient recovered from adverse events after some time. The nurse reported that on 23-JAN-2009 they decided they were going to wait to give the second dose of GARDASIL. It was reported that the patient did not seek medical attention. Additional information has been requested.
I was having irregular heartbeats. It felt like my heart rate was beating out of whack. When I went to the ER, they did an EKG. I have supraventricular tachycardia. They order a heart monitor and to they told me to follow up with my primary doctor. I did a blood test to see if I had a heart attack but it came back fine.
Fever,  chills, joint pain, headache, fatigue, insomnia, nausea, dizziness started after I went to sleep, around 12 am and continued all night until I woke up at 9:30 am
blood sugar was 500/high blood sugar; fainted because of hypoglycemia; fainted because of hypoglycemia; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller mentioned her oncologist who stated that his wife didn't have diabetes. Ten days after his wife (patient) got the second dose of the Covid Vaccine her blood sugar was 500.  Caller stated that her oncologist wife was placed on medication for the high blood sugar and then fainted because of hypoglycemia.  She says the wife was taken back off of the medication and was fine. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of blood sugar increased due to temporal relationship.  The events 'fainted because of hypoglycemia' were associated with blood sugar medication and unrelated to BNT162B2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Cold sweats; Headache; Hard lymph node; Hot to touch lymph nodes; Fever; Chills; Racing heart; High blood pressure; Pain at injection site; Pain at axiillary lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), PALPITATIONS (Racing heart), HYPERTENSION (High blood pressure) and VACCINATION SITE PAIN (Pain at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), PALPITATIONS (Racing heart), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Pain at injection site) and LYMPH NODE PAIN (Pain at axiillary lymph node). On 21-Jan-2021, the patient experienced LYMPHADENOPATHY (Hard lymph node) and FEELING HOT (Hot to touch lymph nodes). On an unknown date, the patient experienced COLD SWEAT (Cold sweats) and HEADACHE (Headache). On 22-Jan-2021, LYMPHADENOPATHY (Hard lymph node) and FEELING HOT (Hot to touch lymph nodes) outcome was unknown. At the time of the report, PYREXIA (Fever), CHILLS (Chills), PALPITATIONS (Racing heart), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Pain at injection site), LYMPH NODE PAIN (Pain at axiillary lymph node), COLD SWEAT (Cold sweats) and HEADACHE (Headache) outcome was unknown.
06/10/04: phone call from mom. son has blisters like lesions, itching. Fever 99.0degrees. Blisters all over some crusting over. Did not go to doctor or seek treatment using oatmeal baths and Benadryl. Questioned Varivax effectiveness. Support offered.
Fever, chills, body aches, headache, lightheadedness, dizziness
high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.
Woke up with chills, fever, body aches, uncontrollable shaking, muscle pains, unable to walk, weak, achy, tremors, head ache
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 04-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335: