chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider:DO Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Severe sepsis (HCC) COVID-19 virus infection    HOSPITAL COURSE: Patient is a 76 y.o. male w/ a pertinent PMHx of Dementia, HTN and orthostatic Hypotension, Chronic Pain, and several other medical issues  who is admitted to Hospital on 7/22/2022 for COVID-19 infection.   Initially upon his presentation the patient had mild tachycardia but otherwise stable vital signs.  He was saturating well on room air.  Laboratory workup revealed COVID infection with a mild elevation of his lactic acid.  The patient acute metabolic encephalopathic.  He was determined to have severe sepsis. He has a history of dementia, however his level of confusion is felt to be worse than his baseline.  Additionally he is significantly weakened by his disease.  He was admitted to the hospital for further management of his COVID, generalized weakness, and acute metabolic encephalopathy.  As he is not hypoxic he was not started on steroids or remdesivir.  He was provided fluid resuscitation.  As he is now eating and drinking all IV fluids have been discontinued.  His laboratory studies remain relatively stable.  His lactic acidosis has resolved. His encephalopathy resolved and he was at his baseline dementia.
01/29/2021 (1st dose): A few days after the vaccination I developed some raised red spots that itched slightly: inside upper right arm, outside lower right arm, on my right hip, and right buttock. Also, I was very achy and fatigued for about 2 days after, as if I had the flu.  03/01/2021 (2nd dose): Sometime in the middle of the night on the 3rd night after the vaccination, I broke out in a much more pronounced raised blotchy red rash at the injection site on my left arm and wrapping around to the front of the same arm. It is a little bit itchy and overall my skin everywhere feels slightly itchy. Also, this second dose made me feel even more sick than the first one. I felt fine for the rest of the first day, but a little stiff at the injection site and a little tired. By midmorning the next day I became achy and increasingly fatigued. By the end of the second day and through the third day I was in a lot of pain and has the chills but without a fever. I was also congested during these two days.  Today, on the fourth day after the injection, I have the rash, as stated, a headache, and am a little fatigued, though mostly back to normal.
rashes; like lots all over his body/rash in the hand; Fever; body is aching/body pain; Sweating; Headache; legs, and soreness; having a reaction; chemical reaction with his skin; breaking out like with pimples; Itchy; getting swollen; This is a spontaneous report from two contactable consumers (patient's wife and patient's son). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's son stated the patient was having a reaction through a chemical reaction with his skin like, he was breaking out like with pimples in Aug2021 and asked if that was normal. The patient also had like a rash over, rash like rash in his body that he was just like make some itchy and getting swollen and then fever and then like legs, and soreness. The patient's son said the patient had like rashes and like lots all over his body and he had headache and then sore and all that. The patient's wife stated the patient got the rashes and he had fever and his body was aching. The patient had not gone to the hospital yet. She stated they got the shot yesterday (15Aug2021) and 2 hours later the patient got the fever, sweating, pain and body pain and rash in the hand. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
as if his tongue and lips had "this 4 hour taste of something, close to bicarb soda harshness"; Had a slight headache (2 frontal sides); This is a spontaneous report received via COVAES. A contactable consumer (patient) reported a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 12Feb2021 16:00 (at the age of 67 years old) as dose 1, single for COVID-19 immunisation. The patient was diabetic and had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 12Feb2021, the patient had a slight headache (2 frontal sides). There were no swelling and rashes. On 12Feb2021 16:35, about 35 minutes after the injection, the patient reported as if his tongue and lips had "this 4 hour taste of something, close to bicarb soda harshness". The patient did not receive any treatment. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had 101 fever Sunday evening. We gave him 400mg of IBU at 6pm and 500mg of Tylenol at 10pm. His fever was gone in the morning.  Monday morning, lymph nodes under his arm were swollen to the size of quarters. Pt upper arm was swollen and red around the injection site the size of a softball. The redness and swelling of the lymph nodes have been slowly diminishing.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F. Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
PT caught Covid after COVID vaccine; PT caught Covid after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "PT caught Covid after COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information a contributory role of BNT162B2 to the reported events COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
pt recv vax 1JUL96 & 20min p/vax pt exp a swollen arm;2 or 3 days p/vax pt exp a linear rash from shoulder to shoulder;
Rapid heart beat; Too sick; Unable to get up; Difficulty breathy; Bad headaches; Fever/ 101.4; Body aches; Little nausea; Exhausted/fatigued; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), ILLNESS (Too sick), MALAISE (Unable to get up), DYSPNOEA (Difficulty breathy) and HEADACHE (Bad headaches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HEART RATE INCREASED (Rapid heart beat), ILLNESS (Too sick), MALAISE (Unable to get up), DYSPNOEA (Difficulty breathy), HEADACHE (Bad headaches), PYREXIA (Fever/ 101.4), MYALGIA (Body aches), NAUSEA (Little nausea) and FATIGUE (Exhausted/fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Rapid heart beat), ILLNESS (Too sick), MALAISE (Unable to get up), DYSPNOEA (Difficulty breathy), HEADACHE (Bad headaches), PYREXIA (Fever/ 101.4), MYALGIA (Body aches), NAUSEA (Little nausea) and FATIGUE (Exhausted/fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.4 High. On 15-Feb-2021, Heart rate: High.          Concomitant product use was not provided.  Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: No specific follow-up information recorded.
Swollen lymph node 3 weeks later under the opposite arm; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient received the injection in right arm at D0. No other symptoms were reported. No treatment medications were reported.
Patient noticed today, 2 days after vaccine, that arm is red, and sore to touch.
3 days after receiving flu shot pt. had a dizzy spell. Pt. experienced two more dizzy spell over next few days. Pt had fast heart beats, headache, muscle ache, fatigue.
I had bloodwork done and my creatinine levels were high. They were at 1.45. I have had an ultrasound done on my kidneys and there was nothing unusual done. I had bloodwork done on March 10, 2023. My creatinine was at 1.13. I am scheduled nephrologist on May 03.
First does  got red dots itching around the body, entire left side body vein in pain due to I had injury on my left arm in early 2017, the pain came back more seriously, some random pop up red points press in pain around the left arms. Second dose, head ache, the night, the left arm's bone was on fire, and left knees' joints was in pain. Next day, fever, entire body got random pop up red points press in pain, muscle tired, left side of the body vein are in pain. No poop.
Dizziness, Headache, Thrombocytopenia, Anemia, Diarrhea, NauseaVomiting Palpitations, Syncope,  Bradycardia  fatigue. some SOB  Narrative:   onset of s/s three days after shot, worsening where she sought medical care on day 10, transferred from office to ED after vomiting and passing out in the office. in ED found to have new dx of bradycardia and anemia and low platelet counts in 110s. being followed by PCP as outpatient.
Pt was administered on R th IM upper-DTaP .5cc, lower-IPV IM .5cc on 8/29/03. Was seen at urgent care for redness, 3 in diameter on R upper th- called our office for f/u on 9/2/03. Site is cleared up. Immunization reaction.
The vial expired on 29-Jan-2022 and was stored in the refrigerator.; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The vial was initially stored in the refrigerator on 11-Feb-2022. The vial did not undergo any temperature excursions. Also reported dose administered after 30-day use by date or after manufacturer date of expiry. The patient received 1/2 dose booster on 11-Feb-2022.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contains no new information.
DIARRHEA, FEVER 103.2 FOR 5 DAYS, DIFFICULTY BREATHING, SLIGHT WHEEZING, SEVERE CONGESTION, HIGH PITCHED SCREAMING, FUSSINESS, SLEEP DISRUPTIONS, RED RASH ON CHEST, HOT HARD LUMPS IN THIGHS AT INJECTION SITE THAT WERE TENDER TO THE TOUCH-CHILD CRIED/SCREAMED WHEN TOUCHED-LASTED 7 DAYS
Chills, 99.5F, Aching all over, Tiredness. Soreness to touch in left arm continued until 08-29-2018. Took One Acetaminophen 500 mg every 4 hours from 4:00 PM 08-25-18 until 4:00 AM 08-26-2018.
I expected to have flu-like symptoms the next day and I did; fatigue, body ache especially my legs, chills, etc.  That went away in about 24-36 hours.  On Monday, I realized I had developed numerous subcutaneous hive-like lumps in the muscles of both thighs.  They are not particularly itchy or bothersome but numerous and they stop around both knees.  They feel like large mosquito bites under the skin and they are less noticeable when not showering.  The heat of the water must exacerbate the issue.  I have asked others and not one else has had this response.  I still have these lumps and plan to visit my MD tomorrow.  I also have developed a wheeze/cough.
This spontaneous report was received from a 73 year old female consumer referring to herself. The patient medical history included gall bladder surgery. The patient's drug reactions/allergies included morphine and CECLOR. The patient's concomitant medications were reported as none. In 2015, the patient was vaccinated with ZOSTAVAX injection, subcutaneously, vaccine dose to prevent shingles (anatomical location, lot # and expiration date were not provided). Additionally, on 15-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 injection for prophylaxis (dose, frequency, route, lot # and expiration date were not provided). On 16-JAN-2018, the patient was diagnosed with shingles. The patient sought medical attention and was treated with an unknown number of unspecified medications. At the reporting time, the outcome of herpes zoster was reported as not resolved as the patient was still not 100 per cent recovered. None laboratory studies were performed. The reporter did not assess the relatedness between ZOSTAVAX or PNEUMOVAX 23 and the herpes zoster.
Since 10 December he has complained of near-daily recurrent episodes of rashes described as flat to raised, red, itchy spots and whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He notes involvement of his palms; palmar lesions described as painful and burning. He endorses daily transient laryngeal symptoms (throat swelling) without clear food triggers. He denies pulmonary, GI, neurologic, and cardiovascular symptoms outside of two interval episodes of loose stools and a single episode of vomiting not associated with cutaneous symptoms or clear trigger. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his COVID19 vaccine booster dose on 27 November, 13 days prior to onset of symptoms. He has used oral antihistamines with partial control of symptoms. He received a single oral corticosteroid course with limited benefit. He denies constitutional symptoms.
Headache, Nausea Vomiting, InjectionSitePain Narrative:
This spontaneous report was received from a healthcare professional referring to a 17 year old patient of unknown gender. The patient's concurrent and historical conditions were not provided. On 08-FEB-2016, the patient was vaccinated with PROQUAD (Merck) (lot number and expiration date were not provided) dose, route were not reported; which was outside of the recommendations in the PROQUAD (Merck) prescribed information (inappropriate schedule of drug administration). No concomitant medications were provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: negative. There 8 patients total passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. The above patients' pulse oxygen saturation levels ranged 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200376657 same reporter/drug, different event with similar event. Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
56 yo male here for Covid-19 vaccine clinic, presented to Urgent Care shortly after receiving vaccine to RUE with local swelling to the injection site. No evidence of anaphylaxis or allergic reaction.
Soreness at injection site - Day one Weakness + tired - Day two Sweaty but no fever - Day two Slight heart palps(one occurrence) -Day two Lasting 2 1/2 days
Developed Angioedema and urticaria after receiving DTaP/MMR/IPV boosters within few hours.
Pt received MMR on 1/10/09.  On 1/18/09 at 2am, Pt noted with 103F temp at home, with tonic clonic seizure and macular body rash.  Taken to ER, evaluated and released.  Pt now stable at home.
sensation like he is a little out of balance; 5 on a scale of 1-10 on lightheadedness; felt like he had "drank a big glass of vodk; night is when he feels worse; hasn't slept in 2 days; Significant fatigue; feeling of being off-balance; Dizziness / Light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / Light-headedness), DIZZINESS (5 on a scale of 1-10 on lightheadedness), BALANCE DISORDER (feeling of being off-balance), BALANCE DISORDER (sensation like he is a little out of balance) and FEELING DRUNK (felt like he had "drank a big glass of vodk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Dizziness / Light-headedness), BALANCE DISORDER (feeling of being off-balance) and FATIGUE (Significant fatigue). On 30-Mar-2021, the patient experienced INSOMNIA (hasn't slept in 2 days). On 01-Apr-2021, the patient experienced FEELING DRUNK (felt like he had "drank a big glass of vodk) and FEELING DRUNK (night is when he feels worse). On 02-Apr-2021, the patient experienced DIZZINESS (5 on a scale of 1-10 on lightheadedness) and BALANCE DISORDER (sensation like he is a little out of balance). On 01-Apr-2021, FEELING DRUNK (felt like he had "drank a big glass of vodk) had resolved. On 16-Apr-2021, DIZZINESS (5 on a scale of 1-10 on lightheadedness) had resolved. At the time of the report, DIZZINESS (Dizziness / Light-headedness), BALANCE DISORDER (sensation like he is a little out of balance), FEELING DRUNK (night is when he feels worse), INSOMNIA (hasn't slept in 2 days) and FATIGUE (Significant fatigue) outcome was unknown and BALANCE DISORDER (feeling of being off-balance) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information  received on  27 May 2021 contains outcome of adverse event(dizziness)updated.
I did not have an adverse reaction to the vaccine. I started not feeling well on 02/03/2023 with cold like symptoms. I tested positive for COVID-19 on 02/04/2023.  I contacted my doctor and was given prescription for Paxlovid.  I had no complications taking the prescription.  My estimated due date is 08/25/2023.
No additional symptoms reported; patient received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a medical assistant and it refers to a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-NOV-2019, the patient was vaccinated with unspecified dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #S002497, expiration date: 23-JUL-2020 for prophylaxis (dose number and route of administration were not reported). Albumin status has been verified as recombinant human albumin (rHA). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with a properly stored diluent. Administered dose of vaccine experienced the temperature excursion of 6.5 degrees Fahrenheit for 20 minutes, previous temperature excursion included 8.1 degrees Fahrenheit for 25 minutes. Digital Data Logger was involved. There was no additional symptoms reported.