chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body feels heavy like lead  Very tired Minimal pain at injection site  2:18pm hands twitching and my right eye feels like it's swollen and burning closer to my cheek and then started twitching uncontrollably. Very dry mouth.  Moments later body tremors and vomiting.  Ended up being taken to the emergency room will elaborate later.   Drink Sprite on the way home vomited it up as soon as I walked in the door. Not the feeling of nausea just the vomiting is coming. Took temperature have a fever of 101.0   DAY 2  Tremors while walking Headache Body aches  Minimal taste  Tingling around eye  No real desire to eat Managed to keep some noodles down  Today is Day 3 5:00am  Still unsteady on feet when walking Still have headache and body aches
pt had tonic clonic movement of upper limbs lasting less than 5 minutes. no apnea, cyanosis. Pt turned red @ that time Pt not himself after episode.
Began feeling ill; Nose is so stuffy; Breathing out of mouth; Sounds like a mouse; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse). On 08-Aug-2021, MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
employee c/o shakiness, rapid heart rate, headache and itching after receiving Moderna Covid-19 vaccine. Evaluated by EMS on site. benadryl 25mg administered PO at 14:15pm. family member was contacted and arrived to drive employee home to monitor
Patient received 0.5ml dose instead of the 0.25ml dose of the 6 moths through 11 years moderna covid vaccine
experience nausea; This is Spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246), via an unspecified route of administration on left upper arm on 13Jan2021 09:30 at single dose COVID-19 vaccination.  Medical history included high blood pressure and prediabetic. Patient reported that she has high blood pressure that she is on medication for. She said she takes Metformin twice a day, clarifying she is pre-diabetic according to her Hemoglobin A1C. Patient was on top of her bloodwork, saying she has her bloodwork done regularly. Reported patient's height was 4'11" or 5'. Concomitant medications included Metfiormin as patient is pre-diabetic. Reported she has had the flu and Shingles vaccines in the past, and never had any prior reactions to vaccines. No prior vaccinations (within 4 weeks). The patient had her first dose of the Pfizer COVID-19 Vaccine yesterday morning, 13Jan2021, at 9:30. She said she had some nausea last night. She said she woke up in the middle of the night with nausea. She said she woke up this morning and had nausea again, but ate something and got better. She said the nausea is like morning sickness, clarifying if she eats something the nausea goes away, but once her stomach is empty, the nausea comes back. She said she has not had a fever. She asked how long should she expect her nausea to last. The event did not require a visit to Emergency Room or Physician. The outcome of the event was not recovered.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/02/2021.
pericarditis- inflammation in his heart; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:00 (received at the age of 30-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in the hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. Medical history included Cancer, MRSA (Methicillin-resistant Staphylococcus aureus), Chemotherapy, SVT (Supraventricular tachycardia) Heart Arrhythmia X2 hospitalizations, Pericarditis, and COVID-19. The patient had no known allergies. There were no concomitant medications.  The patient went to the E.R. (emergency room) twice for pericarditis- inflammation in his heart on 21Jul2021 14:00. Therapeutic measures were taken as a result of the event which included Chochicine, Bayer Aspirin, GI Cocktail, Prilosec. Outcome of the event was not recovered. The adverse event resulted into doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
tested for Covid and the result was I was positive; tested for Covid and the result was I was positive; coughing; sneezing; nose blowing; body aching; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single and also received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as, Single Dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced tested for covid and the result was he was positive and also had coughing, nose blowing, body aching. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events drug ineffective, covid-19, cough, sneezing, nasal congestion, pain was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pink area is bright red...now a solid red color; arm felt very itchy; Fever; her arm was very sore; faint pink splotchy rash size of half dollar inch below where injection occurred; Fatigue; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.   The patient's medical history included asthma, osteoporosis, cardiac arrythmias, seasonal allergies and hematuria.   Products known to have been used by the patient, within two weeks prior to the event, included salmeterol inhaler, budesonide inhaler, montelukast sodium, guaifenesin, levothyroxine sodium, ubidecarenone, tolterodine L-tartrate, vitamin D, biotin and cetirizine.    The patient received their first of two planned doses of mRNA-1273 (LOT# 037K20A) on 28-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 28-Dec-2020 in the left arm at approximately 1300.  She reported that 12 hours later, her arm was very sore, however, she had expected that.  On 29-Dec-2020, she reported that there was a half-dollar sized, pink, splotchy rash about 1 inch below the injection site. She said that is was raised but did not itch.  Additionally on 29-Dec-2020, she reported having fatigue.  Patient reported that the fatigue resolved over the course of a week and that the rash began to disappear.  However, one week later, on 04-Jan-2021, her arm felt very itchy and the area that used to be pink had become red and patchy looking and continued to increase in size and become more reddened. Patient wished to know if this was normal.   Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not provided.  The outcome of the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not reported.   The reporter did not provide a causality assessment for the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.
Over 1 year since 1st dose, how to proceed with 2nd; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received over one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Over 1 year since 1st dose, how to proceed with 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Mar-2023 The reporter would like to know how to proceed with second dose if had been over 1 year since the first dose was given. The medical information did not speak with the provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
C/O L arm pain post flu shot. Took Celebrex, Advil, Medrol dose pack without relief. Pt 2x weekly with Biofreeze at imtophoresis. Did not want to see neurologist. Thinks shot was given "too high."
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-May-2021: Contact information updated and included no new information.
Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5 ml, of Gardasil (date not specified). "Soon after the injection," the patient "developed auto-immune disease." The patient sought unspecified medical attention. No further information is expected.
The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic.  Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.
Breakthrough case admission after 3 vaccines Moderna 1/22/21 Lot# 029L20A;  Moderna 2/19/21 Lot# 023M20A;  Moderna 11/21/21 Lot# 058H21A
Red swelling on left arm at injection site; Red swelling on left arm at injection site; Some itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 12:30 as dose 5 (booster), single (Lot number: 6H9703) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "cold agglutinin disease" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 05Oct2022; OLANZAPINE; SYNTHROID; ACTONEL, start date: Sep2022. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 10Oct2022, outcome "recovered" (13Oct2022) and all described as "Red swelling on left arm at injection site"; PRURITUS (non-serious) with onset 10Oct2022, outcome "recovered" (Oct2022), described as "Some itching". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, pruritus.  Additional information: The patient had received other vaccine in four weeks. The patient had no Covid-19 prior to vaccination and patient had not tested COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
overweight; had the sniffles; had a temperature; aches/pains; Headache; right shoulder sore where he got the shot; foggy; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: Unknown), dose 2 on 18Mar2021 as Dose 2 SINGLE for covid-19 immunization (Age at vaccination was 63years).The patient medical included he had Epstein Barr (twice when was a kid so he does not have a strong immune system) and he had taken BNT162B2.Concomitant medications were not reported. On 19Mar2021 the patient had temperature, aches, pain, headache, right shoulder sore and foggy. On an unknown date the patient had sniffles and overweight. The reporter stated that he got the second shot and did not feel anything yesterday. Stated that today he is knocked out. Stated that he had a temperature, aches, pains, headache, right shoulder sore where he got shot and foggy. Stated that everything that they wrote in the thing he got. Stated that he stayed home to drink and rest and he talked to plenty of people and this went away. No further details provided. Stated that he was overweight. The outcome of the events were not recovered. No follow up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: ff8839), in left arm and on 20Apr2022 at 10:00 as dose 4 (booster), single (Lot number: fm9992) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN, start date: 01Jan2017; ROSUVASTATIN, start date: Jan2017, stop date: 01May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of covid-19.   Clinical information: The patient received vaccine and other medications in two weeks. and Paxlovid form 01May2022 to 05May2022 as a Treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.
Patient began experiencing an extreme allergic reaction about 18 hours after the vaccine. He had hives all over his body and 50mg of BENADRYL was not effective. Patient began to have swelling around the mouth and numbness and went to the ER. He received IV BENADRYL and prednisone. Upon returning home he began to react again 24 hours later and had to return to his doctor to get his meds increased.
LEFT UPPER ARM SWELLING WITH REDNESS DEVELOPED ON 10/20/2020 AT SITE OF ONE VACCINATION. AREA IS WARM TO THE TOUCH. MOTHER STATES SWELLING IS THE SIZE OF A SOFTBALL AND IS STILL THAT SIZE. BRUISING TO LEFT ARM WHERE ONE OF THE VACCINATIONS WAS GIVEN. MOTHER REPORTS CHILD HAVING A FEVER OF 101.2-101.4 ON 10/20/2020, BUT DENIES FEVER AT THIS TIME. MOTHER REPORTS NO MEDICATIONS WERE GIVEN. ICE PACK WAS USED AT SITE OF SWELLING; SWELLING HAS GONE DOWN A LITTLE AND REDNESS HAS LIGHTENED. CHILD IS NOT COMPLAINING OF PAIN. MOTHER DENIES PUS, RASH, OR RED STEAKS AT SITE OF SWELLING.
patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed; Vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (Vaccine had been refrozen and rethawed) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (Vaccine had been refrozen and rethawed). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (Vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-381132 (Patient Link).
First developed pains on right side of my face including right eye. Radiated on top of my head same side. Then noticed blisters on my face  and head with severe pains. Prescribed Famcyclovir for 1 week. Presently still suffering pains on my face, head and right eye. Feel dizziness, double vision and extreme tiredness.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021
Patient is fully vaccinated, Developed COVID19 on 02/16/2022, and passed away on 02/16/2022. Patient is currently being investigated by the review team to determine if death was COVID related.
We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1715 and MA2009-1717 to MA2009-1722). Request was sent on 22 JUN 2009, no follow-up information received.
about 15 hours after dose of vaccine  his daughter could hear him  carrying on, and was standing but not responding to verbal cues. He was confused,  wet himself,  and still doesnt  remember anything about the event or the ambulance ride.  He would not and could not walk, and was sweating, breathing labored, they called 911.     went to  hospital and was admitted  friday morning and was released monday.    patient states his body was in pain from head to toe.   His daughter stated he received antibiotics and fluids and is not sure what else.   Patient is home now and is doing better.
Redness and swelling around injection site, three inches in diameter. Slight pain around site. No other symptoms reported.
had a decrease of her menstrual cycle from 7 days to 2 days; This spontaneous report was received from a physician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 24-FEB-2011, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot # reported as 15602 was evaluated and changed to the valid lot # 1560Z, expiration date not reported, upon internal validation established as 28-APR-2013, route reported as injection; strength and dose were not reported) for prophylaxis.    On 08-MAR-2019, the patient had a decrease of her menstrual cycle from 7 days to 2 days. The outcome of the event was not recovered. The causality assessment was not reported. combinationproductreport: Yes; brandname: GARDASIL SYRINGE (DEVICE); commondevicename: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1560Z; expirationdate: 28-APR-2013; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Around 7 hours after getting the vaccine muscle soreness and extreme headache started Around hour 9 after vaccine a fever spiked, vomiting, and chills that could not stop.  I have never been so miserable in my life I thought I was going to die
Patient developed syncope after administration about 5 minutes after administration. Patient was coherent very quickly and was helped to floor by father and myself. Patient was placed on floor and then moved to chair. Thirty minutes later she walked out of store with no incident.
I26.99 ACUTE PULMONARY EMBOLISM 8/18/2022 CHEST PAIN I26.99 ACUTE PULMONARY EMBOLISM 8/18/2022 FAILURE TO THRIVE SYNDROME, ADULT
15APR99 pt recv vax & the day p/ c/o some warmth in the area;over the weekend became worse devel fever up to 102, malaise, arthralgias, reflux, nausea;some mild tingling in arm;unable to work temp, but improving;