chrisvoncsefalvay/vaers-outcomes huggingface dataset:
86y.o. male with history of hypertension, Diabetes mellitus type II, OSA (uses 2L of O2 at home), CAD, cardiomyopathy, CVA with right hemiparesis, gout, GERD, and depression who presents to the hospital on 4/27/2021 for shortness of breath that has been worsening over the past week. Patient positive for COVID on 4/26/21 when he presented to the ED with fever, cough, and chronic toe infection. Patient had no hypoxia or increased work of breathing and was discharged from ED with doxycyline for his toe infection. Patient reports that he returned to ED due to family concern over symptoms. In ED, patient became hypotensive and was given 30 mL/kg bolus by ideal body weight. Patient remained hypotensive and central line placed in ED for possible vasopressors. Patient is on his home oxygen of 2L and has no increased requirements. Patient in ICU for sepsis and hypotension that responded to IV fluids.
Approximately 10 minutes post vaccine administration patient experienced a tonic-clonic seizure while seated in the pharmacy waiting area. Seizure lasted approximately 30 seconds (+/-).  No past history of seizure. EMS responded.  Patient was alert and conversant within 3 minutes.   Patient was released by EMS to her mother for transport for further medical evaluation by her doctor.
Student passed out sitting in chair a few minutes after receiving the vaccine. This was witnessed and medical care was at student side immediately. SPO2-94% HR-80. 2:41p Student opened eyes spoke then passed out again while in chair. Student was lowered to ground x3 assist and legs elevated on chair BP-120/78, SpO2-96%, HR-57 cold and diaphoretic. 2:48p BP-100/72, HR-80, SpO2-99% student alert and talking legs repositioned on floor without issues. 3p assisted to standing position x2 assist then to chair. 3:10p ambulated with standby assist without issues. Vitals checked every 5-10 mins and remained stable. Student admitted to having similar episode in Summer 2019 with blood draw. Student had little to drink and nothing to eat this day. 3:15p Student?s roommate arrived to walk home with student. Encourage student to eat and drink plenty of fluids for remaining day and ensure that he eats and drinks fluids prior to 2nd vaccine dose. 3:30p Student was cleared by PA to leave at his convenience.
Started having chills, lethargy, back pain and weakness. Took a home COVID-19 test and was positive. Contacted doctor but wasn't prescribed anything.
tired; mild fever; is past the 6 months for getting her 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: The patient self reported this case. The patient received the first dose of Shingrix vaccine and the next day she was tired and had a mild fever. The symptoms only lasted a day and had thus resolved. The patient was past the 6 months for getting her second Shingrix vaccine but did plan on getting the second vaccine.  The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case had been linked with case US2022143270, reported by the same reporter.; Sender's Comments:  US-GSK-US2022143270:same reporter - mother of the reporter´s case
Case number PHHY2013US132342 is an initial literature report received on 18 Nov 2013. This report refers to multiple female pregnant patients. The patients were vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported) on an unknown date during pregnancy. The top three reasons women reproted for vaccination were to protect their infant from Influenza (33.2%), to protect themselves from Influenza (20.0%) and because their healthcare provider recommended vaccination (15.7%). The top three reasons reported for non vaccination were concern about safety risk to the infant (20.5%), that the vaccination would give pregnant women Influenza (13.6%), and that vaccination was not effective in preventing Influenza (10.6%). The author concluded that education messages for pregnant women needed to emphasize that vaccination during pregnancy can protect not only pregnant women themselves but also their infants during the first 6 months of life.
He got Fever on 29th and on 30th Sept. 2022, Fever between 101 F to 102 F. He also got bad headache for two days and  He also vomited on 29th Sept night time and 30th Sept night time.   His pediatrician told us to give him Tylenol (160 mg per 5 ml) , 6ml and monitor him. So we gave him as following, 1. 1st 6ml: 7:35 PM on 29th Sept 2022 2. 2nd 6ml: 4:35 AM on 30th Sept 2022 3. 3rd 6ml: 12:21 PM on 30th Sept 2022 4. 4th 6ml: 9:40 PM on 30th Sept 2022.
Information was received from a licensed practical nurse concerning a 13 month old male who on 23 FEB 2005 was vaccinated with a dose of Varicella vaccines.  On approximately 07 MAR 2005 the patient developed chickenpox rash and fewer than 50 vesicular lesions. No other symptoms were reported.  Unspecified medial treatment was sought.  The report indicates that the patien was recovering.  No product quality complaint was involved.  Additional information was requested.
Flu vaccine administered to left deltoid, IM. Bruise noticed after injection. She states she felt weak & dizziness occurred. Felt as if she might pass out. She sat and monitored for 1 hour. Ice applied to left arm. She drank a bottle of water and vital signs taken. She states she felt better and returned to work.
Systemic: Dizziness/Lightheadedness-Medium, Systemic: Exhaustion/Lethargy-Mild, Systemic: Flushed/Sweating-Medium.
Arm swollen & red at injection site progressing to swelling of under arm down to the elbow very red & painful. Last about 1 1/2 wks. Tool ibuprofen, TYLENOL & prednisone given by dr.
Rheumatoid arthritis flare up; PAIN; This is a solicited report from the marketing program facilitated collect received based on information received by Pfizer (manufacturer control number: 21K-163-4126015-00) from a contactable consumer.  A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date, at 40MG/0.4ML, 1 in 2 week for Crohn's disease. Medical history included ongoing Crohn's disease. No known allergies. Concomitant medication included colecalciferol (VITAMIN D). Historical vaccine included first dose of BNT162B2 intramuscular for COVID-19 immunization.The patient experienced rheumatoid arthritis flare up, medically significant and pain, non-serious in 2021.  The patient underwent lab tests and procedures which included pain assessment: 2/10 on unknown date. The patient was recovering from the event, rheumatoid arthritis flare up and outcome of the event pain is unknown.  The reporter's assessment of the causal relationship of event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious and non-serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Patient was given Moderna vaccine beyond the published expiration date. Per Moderna Manufacturer, re-vaccination is not required, vaccine was deemed to still maintain activity necessary to protect patient against Covid-19.
felt dizzy; Plapitation; tachycardia; Blood pressure went up; clammy; headache; cold and clammy; A spontaneous  report was received from a physician concerning a 74 year old, female patient who received  first dose of Moderna's COVID-19 vaccine and experienced headache, dizzy feeling, chill, palpitation, blood pressure went up, clummy and tachycardia.    The patient's medical history was not provided. Concomitant product used was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot no: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced headache, dizzy feeling, started getting palpitation, her heart beats was 132 bpm. her blood pressure increased and oxygen levels were normal and the patient did not required oxygen. She started feeling cold and clammy and was in injection area of hospital for 2 hours with constant monitoring. She did not take any medication but drank lots of water.   The patient was concerned of whether she should receive the second dose given the symptoms experienced after the first dose.    Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events headache, dizzy feeling, chill, palpitation, clammy, blood pressure went up and tachycardia were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Left shoulder pain started 2-3 hours after injection the next morning unable to lift arm 3 weeks after able to lift with pain.
Employee became nauseous and vomited approximately 40 minutes after receiving 2nd dose of Heplisav-B. Employee rested and tried to eat but was having abdominal pain and dizziness. Employee vomited again after another 45 minutes and notified medical staff.  No signs or symptoms of adverse reaction at sight of injection, temperature 98.2 degrees Fahrenheit. Employee has not had any further symptoms.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 45.90 for dose administered on 15-Apr-2021. No concomitant medications were reported.  Batch number 044B21A administered on 15-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
had fever 102 for about 24-48hr & felt tired;pt had had the flu vax for several years a/this year;
Started running a low-grade fever and been running one consistently for over a week. Feel generally weak, somewhat disoriented and not well AT ALL! What the heck are those people putting in the flu vaccine this year?!
Stomach ache everyday. It feels like stabbing pain. It started on 12/02/2021 to present. Went to the emergency and was treated and sent home with intestinex capsules. Will follow up with a pediatrician.
left thigh red and warm, mild swelling, no induration, no evident tenderness after 12 hours after vaccine. no treatment required.
Headache, Fever, CoughWheeze, RUNNY NOSE, FATIGUE, SOB, SORE THROAT, STUFFY NOSE Narrative:
Dtap vaccine +  mild reaction (rash).; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a 73-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced rash (Verbatim: Dtap vaccine +  mild reaction (rash).). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Tdap Vaccine.     It was unknown if the company considered the rash to be related to Tdap Vaccine.   Additional Information: GSK receipt date 18 Jul 2023: The patient needs Boostrix. The patient was administered TDaP in 2007 and had a mild reaction (rash).   The reporter would like to know whether or not it would be safe to administer Boostrix to her. The reporter consented to follow up.
the immunizer that administered Covid vaccine for the health facility. He was inc,orrectly given a list of patients that needed to receive a second dose of the Covid vaccine. Unfortunately, the patients had already received their second dose on 2/2/2021 and were not able to communicate the receipt of this dose.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
pATIENT States that the following day he has extremely swollen and pAINFUL LYMPH NODES IN THE UNDERARM AREA
Myalgia, UrticariaPruritus, FATIGUE, ARM SORE/RED/ITCHY AT INJECTION SITE X 5DAYS Narrative:  Other Relevant History:
a very severe painful kidney reaction, pain is fluctuating; a very severe painful kidney reaction, pain is fluctuating; This is a spontaneous report from a contactable pharmacist.  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 20Aug2021 (Lot Number: EW0918, Expiry date not reported) as dose 2, single for covid-19 immunization.  The patient medical history included "hematochromia" (discrepantly reported).  The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Lot Number: EW0191) as dose 1, single for covid-19 immunization.  On an unspecified date, the patient experienced a very severe painful kidney reaction and the pain is fluctuating. It was reported the patient refused to go to emergency room. Treatment for the events was not reported. The outcome for the events was not reported.
Edema, warmth, redness, pain to left arm, including bicep, shoulder, forearm, armpit. Redness and edema to left side of face, and neck. Tingling and weakness to right leg. Left shoulder and elbow joints enlarged. Redness to left side of back/shoulder blade. Visit to well key clinic on 2/20/21- treatment included rocephin shot 1 gram to buttock, dexamethasone 4 mg injection to buttock. Doxycycline 100 mg BID x 7 days. Medrol dose pack. Symptoms are unresolved at this time.
positive for Covid 19 on 1/27/22.  His symptoms have been relatively mild and he has not required medical intervention.  He is scheduled for major surgery on 2/15/22 which
pt recv vax; rash on face, neck then all over; swelling in neck; fever; body aches specifically neck & shoulder areas;
The patient was given 0.3 ml of undiluted Pfizer vaccine. Explained to patient what had happened as soon as realized.  Patient waited in clinic for 30 minutes following the injection without any adverse side effects.  Patient left accompanied by a friend.   Spoke with patient by phone 02/17/22 at 3:45 pm.  Patient chuckling, says he feels fine and states "I feel just like I always do."
was given expired ipol with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves patient of an unknown age and gender who was given expired IPV (Vero) [Ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jul-2022, the patient received an unknown dose once (total) of suspect IPV (Vero) (Suspension for injection; strength: standard) (lot: T1D482N; expiry date: 25-Jul-2022) via unknown route in unknown administration site for immunization.  On 27-JUL-2022 the patient was given expired IPV (Vero)with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills; nausea; sore throat; malaise; threw up; severe headache; This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Bexsero (intramuscular). On 20th August 2019, 8 days after receiving Bexsero, the patient experienced chills, nausea, sore throat, malaise, vomiting and headache. On an unknown date, the outcome of the chills, nausea, sore throat, malaise, vomiting and headache were unknown.   It was unknown if the reporter considered the chills, nausea, sore throat, malaise, vomiting and headache to be related to Bexsero.  Additional details were provided as follows: The reporting physician was the patient's parent. The patients experienced a severe headache and threw up a couple to times. The reporter was currently in the woods camping and was unable to provide any physician information and had limited phone service. The reporter did not consent to follow-up.
Three (3) people drying after receiving the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Three (3) people drying after receiving the second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - This case concerns a female patient of an unknown age  with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age  with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death