chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission: 9/20/2022 Discharge Date: 9/22/2022  PRESENTING PROBLEM: Hypoxia [R09.02] Elevated troponin [R77.8] AKI (acute kidney injury) COVID [U07.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 73 y.o. female who presents today with fatigue. pmh htn,obesity,gerd, depression and anxiety, dm 2. Notes onset today with " non feeling well. Noted onset feeling shaky and legs feeling weaker than normal.    In ed found to be hypoxic to 88% on room air requiring 2 l nc o2. cxr neg for acute process. Febrile to 38.1 tachycardic , rr elevated . Labs with creat 1.36 last obtained in 2017 0.69. troponin baseline 22 with 2 hr pending . Ecg with diffuse t inversion v1 v6 no st abnormality. Lactic 1.2 cbc normal ranges . Tested positive for covid . Given fluids 2 liters , decadron ,tylenol in ed .  Hospitalist service consulted for admission further evaluation.  She was continued on COVID-19 therapy with dexamethasone and remdesivir.  She was continued on severe respiratory isolation.  Supplemental oxygen was continued and weaned to room air.  She is noted to have continued generalized weakness needing assistance greater than her baseline.  PT/OT evaluated and advised home with assist and no additional services needed upon discharge.  MSW/CM on board for discharge plan referral and arranging outpatient services. Electrolytes were monitored and repleted throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
Pt c/o swelling of throat and itching in mouth approx . 20min after vaccine administration.
May 2003: Irregular heartbeat, edema of lower extremities, tired easily. Dx with Hashimotos thyroiditis. Rx 6/10/03 Synthroid .025/day. 8/1/03 Diagnosed with pericarditis. Admitted to hospital.
swelling began in feet and moved up legs to abdomen; 25 lb weight gain in two weeks between routine doctor exam and emergency visit leading to hospital admission for 6 days where an atrial flutter was detected that was not present in May 19th exam. Diuretics in the week since admission have pulled off over 35 lbs and vastly reduced swelling but heart damage remains.
lethargy, body aches began 2 days after injection, lasting about 24 hours per pt; resolved completely.  Narrative: lethargy, body aches began 2 days after injection, lasting about 24 hours per pt; resolved completely.
Fever; Chills; Lethargy; Muscle pain; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0196) intramuscularly administered in the arm right on 21Jun2021 10:00 as dose 1, single for covid-19 immunization. Medical history included psoriasis from 1999 and ongoing; adrenalectomy from 2004 and ongoing; and schwannoma from 2012 and ongoing. Relevant test included negative PCR on 06May2021. The patient was previously vaccinated with a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0186) intramuscularly in the left arm on 09Jun2021 13:00 for covid-19 immunisation and experienced vaccine had been in the freezer beyond the approved timeframe. Concomitant medications were not reported. On 01Jul2021, it was reported that the 1st dose was repeated on 21Jun2021 as recommended due to the Pfizer-BioNTech vaccine received on 09Jun2021 had been in the freezer beyond the approved time frame prior to being administered and the effectiveness cannot be guaranteed. On the repeated 1st dose, the patient experienced fever and chills (seriousness criteria: medically significant, persistent/significant disability/incapacity) on 21Jun2021 at around 6-7 PM and received Tylenol for both events. The patient also experienced lethargy and muscle pain (seriousness criteria: medically significant, persistent/significant disability/incapacity) on 21Jun2021 at around 6-7 PM but did not receive any treatment for these events. The patient recovered from all the adverse events on an unspecified date in 2021.  Information about batch/lot number has been requested.  Follow-up 22Jun2021: Follow-up attempts are completed. No further information is expected.  Follow-up (01Jul2021): New information received from a contactable pharmacist includes: historical vaccine data (previous vaccine received on 09Jun2021 was updated as historical vaccine), medical histories added, suspect vaccine data (new vaccine dosing information reported), reaction data (added events fever, chills, lethargy and, muscle pain; deleted previous event "vaccine was in the freezer longer than it was supposed to be before it is administered, it might not be effective; First vaccine that she was administered will not be counted") and, clinical course information. Case was upgraded to serious.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events pyrexia ,chills,lethargy and myalgia. 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.,Linked Report(s) : US-PFIZER INC-2021701731 same reporter, same drug, different patient.
The recipient developed itching ~ 2 hours after receiving the vaccine. She was at home when it occurred. She called her PCP about 6 hours after the dose due to severe itching and hives. She "received treatment" unknown what type and the hives went away overnight.
Patient experienced syncopal/fainting episode approximately 10 minutes after receiving H1N1 vaccine (IM). Patient struck head on floor. Complained of headache - No visual disturbances. Parents refused transport via to local Hospital.
Consistent dry cough that happened right after the 2nd shot; Sore arm; Fatigue; This is a spontaneous report from a contactable healthcare professional. the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew 0153) via an unspecified route of administration in the left arm on 13Apr2021 at 19:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and post-traumatic stress disorder (c-ptsd). The patient had no known allergies to medications, food or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and fexofenadine hydrochloride (ALLERFLEX) for unknown indications, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient had not been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep 7534) via an unspecified route of administration in the left arm on 23Mar2021 at 20:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 20:00 right after the second shot patient experienced consistent dry cough. It is been three days now and it still had the cough, sore arm and fatigue had went away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had been tested for COVID-19, which included COVID-19 virus test (nasal swab) on an unknown date and tested negative. The clinical outcome of the events sore arm and fatigue was recovered, on an unknown date in Apr2021. The clinical outcome of the event consistent dry cough that happened right after the second shot was not recovered, at this time of report.   No follow-up attempts are needed. No further information is expected.
2 days post-vaccine raised red bump approx. 2 inches in diameter at injection site, warm and painful to touch treating with cold pack
Swollen armpit about 5 days after my first shot. Still a bit swollen today (9 days later). Also, starting yesterday (day 8) occasional itching near injection site. So far, only day of itching.
Pain in arm, headache, sore throat x 2 days. Swelling at site, redness at site, hot to touch, and itchy.
No adverse event; Given dose of bivalent vaccine as first dose of COVID-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines) 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 WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines).    Concomitant product use was not provided by the reporter. Patient did not received any other vaccines in the four weeks prior to COVID-19 vaccine. Treatment information was not provided.
Developed arm soreness 1 day after vaccination, then developed axillary soreness and swelling 2 days after vaccination which progressed overnight before mostly resolving 3 days after vaccination. No systemic symptoms or injection site swelling/reaction noted.
On 9/17/01, complained of burning in left leg. On 9/18/01, awoke with eruption. On 9/20/01, rash was seen and evaluated. Eruption in dermatome pattern. In treatment and anticipate recovery.
The patient's past medical history included No adverse effect (no adverse event reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 antibody test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Healthcare professional (HCP) called in to report multiple adverse events and asked if she should receive the second dose. Adverse events included headache, fever, chills, chest pain, heart palpitations.
Pt. received vaccine 7/12/12. Reported a rash/rxn at injection site on 7/13/12, red, raised area about baseball-sized still evident on 7/15, slightly itchy, warm to touch. Took BENADRYL 7/15 upon talking to RPh.
From phone contact received at a manufacturer on 4/25/02, it was reported that a 29 y.o. female received Imovax IM - 2nd dose for pre-exposure series administered on 4/11/02. PT developed tingling and numbness in right arm where vaccination given. Also experienced neck problems on left side, headache and abdominal discomfort w/in 24 hrs.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-409900, MOD-2021-409905 (Patient Link).
Narrative: 94yo male patient with PAST MEDICAL HISTORY (from last MD chart note 7/16/2018), so list is not current. Anemia of chronic renal insufficiency (SChronic atrial fibrillation (SCT 426749004) Congestive heart failure (SCT 42343007) Atrial Fibrillation (ICD-9-CM 427.31) Tobacco user (ICD-9-CM 305.1) Mixed Hearing Loss, unspecified (ICD9- CM 389.20) Arrythmia (ICD-9-CM 427.9) Congestive Heart Failure (ICD-9-CM 428.0) Hypertrophy (Benign) of Prostate withoutErectile Dysfunction (ICD-9-CM 302.72) Anemia (ICD-9-CM 285.9) Mixed conductive and sensorineural hearing loss (ICD-9-CM 389.2) Mixed hyperlipidemia (ICD-9-CM 272.4) HYPERTENSION NOS (ICD-9-CM 401.9) Pt died on 01/02/2022 of unknown causes or circumstances outside of facility hospital. Last chart note in facility from 2/24/2021. Pt had received covid vaccines on 1/21/21 & 2/24/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
c/o violent chills and flu like symptoms for about 3 hours after receiving injection. severe body aches and 99.9 fever. those symptoms resolved but continues to feel fatigued
I have damage to my immune system as a result of the treatment wherein my small nerves are now seen as foreign and are being attacked by my immune system resulting in chronic pain.
Pain in arm where vaccine was given, shoulder pain during certain motions, numbness radiating into fingers.
No period after 2nd booster (4th dose) August 2022. Period returned 3 September for 4 days then again on 24 September with heavy bleeding 26 & 27 September; still on period.  No period after 1st booster (3rd dose) February 2022. Period returned 5 March for approximately 10 days with heavy bleeding on day 7 (11 March). Product:Pfizer COVID-19 Vaccine; Lot #:FJ1614-PFIZER-2021; Route:Intramuscular;  Site:Right Deltoid.
swollen arm; arm hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (arm hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Guillain-Barre syndrome.    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 PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (arm hurt). At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Within a few minutes after receiving vaccines ? seizure-sent to ER. Pt was witnessed to have a clonic tonic seizure during the appointment. Pt had been given her immunizations and appeared to be doing well. Provider was speaking about the need for possible blood drawn when pt appeared to become nervous. Pt suddenly contracted. Her arms became rigid and then her whole body became stiff as her eyes rolled back in her head. The pt was standing at the time in her mother's arms. Pt was then transferred to the exam table. The seizure lasted approx 30 seconds. She then remained in a postictal state for 4-5 minutes. She gradually became more responsive. Pt's mother agreed to take her to ER for further evaluation. Pt was in stable condition when she left the clinic. The ER was notified of pt's arrival. Report given to RN.
Myalgia 9/10 pain in left arm Narrative:  employee reports not being able to lift arm past chest level. reports lifting heavy objects is difficult and unable to do...endorsed this feeling comparable to a rotator cuff issue he had when he was 14.
Flushing and generalized urticaria within 5 minutes of administration of H1N1 vaccine.  No respiratory/GI/rhinoconjunctivitis symptoms.  No angioedema.  Treated with IM Benadryl with resolution.
Approximately 1-1.5 hours following vaccine administration, patient developed shortness of breath and difficulty breathing.  She was without hypotension, urticaria, wheezing, and or pharyngeal swelling.  The following medications were administered in the emergency department: famotidine, diphenhydramine, dexamethasone, and epinephrine x 4 doses.
Ear has been in so much pain; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Pain in ear, at a dose of 800 mg. At the time of the report, EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Information has been received from a registered nurse concerning a 2 week old patient who on 05-MAY-2008 was vaccinated with a dose of ROTATEQ at another office. Concomitant vaccinations administered on that same day at another office included a dose of PEDIARIX and a dose of PREVNAR. The patient had no symptoms. No further information is available. There was no product quality complaint. Additional information has been requested.
2 days p/DT pt had red,tender & warm to touch 2" area on lt deltoid site w/o fever;
Fever of 100.8; extreme pain and soreness in left with pain spreading down to fingers and up into shoulder and neck; muscle cramps in left arm and left leg; spasms in abdominal muscles on left side; loss of appetite; headache; blurred vision; all-over aches and pains; inability to sleep; unable to use left arm.  With the exception of soreness in the left arm, other side effects subsided 36 hours after onset.
No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 08-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290, expiration date 06-SEP-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt recvd vax on 29JUL92 & the next day woke w/stomach cramps & vomiting which persisted throughout the evening; later pt was able to eat again;
chest pain; out of breath; shiverin; headache; fever; sleeping problems; upset stomach; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included coronary stent placement.   On 30th March 2019, the patient received the 1st dose of Shingrix. On 31st March 2019, 1 days after receiving Shingrix, the patient experienced chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain. The patient was treated with nitroglycerine. On an unknown date, the outcome of the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient had a history of a stent in his heart.  The patient reported that he had the 1st dose of Shingrix at the pharmacy. He started having the following symptoms the day after having the vaccine and he was still having all these symptoms. He feels like somebody was sitting on his chest (he clarified he meant chest pain),out of breath if he walks, shivering, headache, fever, sleeping problems, upset stomach, muscle pain down his leg.  He visited his physician and they thought that his chest pain that he was having was not heart related. He had a dose of nitroglycerine and that did not alleviate his chest pain.  He had a CT coronary angiogram with contrast on 2nd May. The reporter gave consent to follow up.      Lab Comments: CT coronary angiogram was done on 2nd May.
This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received flu vaccine on 9/10/2020. A few hours later, she developed possible seizure like activity and was sent to hospital. There she was diagnosed with sepsis of unclear etiology, improved with broad spectrum antibiotics. Was not sick prior to vaccination, and had tolerated other flu vaccines in previous years. Patient also high risk for aspiration due to advanced dementia and dysphagia, so unclear what precipitated event.  Vaccine was given in patient's home in as part of Program