chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 05Apr2021 at 19:15 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included slightly high blood pressure and body mass index over 30. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included hydroxyzine hydrochloride (VISTARIL), bupropion (MANUFACTURER UNKNOWN), emtricitabine/tenofovir disoproxil fumarate (TRUVADA), ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received pethidine hydrochloride (DEMEROL) for unspecified indication from unknown date and experienced drug allergy. On 05Apr2021, since the date of vaccination, the patient experienced diarrhea. On an unknown date, the patient underwent lab test and procedures which included body mass index (BMI) and the result was over 30. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
she felt very sick; chills; fever; This is a spontaneous report received from a Pfizer sponsored program COVAX US Support.   A non-contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes that she had tested positive to COVID before receiving the 1st vaccine. The concomitant medications were not reported. Caller wanted to know was it ok not to show up for her 2nd appointment because after receiving her 1st dose of the vaccine she felt very sick and had the chills and fever on an unspecified date. At home she took her temperature and it was 99 but when she went to the doctor office it was 97. She read online that she didn't really need the 2nd dose or the vaccine if she already tested positive for COVID. The patient underwent lab tests and procedures which included body temperature: 99, body temperature: 97, SARS-CoV-1 test positive: positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11-17-05 Pt came to office with rash, red bumps with vesicle. Dx  Pass chicken pox. Rx Benadryl PO PRN; isolation.
Pt has a history of CAD, status post CABG, history of lung cancer status post lobectomy, diabetes, and obesity.  She has had 8 days of increased work of breathing at which time she states she caught a URI.  She is COVID positive and admitted with acute hypoxic respiratory failure.
He has some concerns about the side effects he has experienced since receiving the vaccine; This is a spontaneous report received from a contactable reporter Consumer or other non Health professional. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: ANXIETY (non-serious), outcome "unknown", described as "He has some concerns about the side effects he has experienced since receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
39 y.o. male traveling on business x months. Received Rabies #1 2/15/10, reports elbow joint pain bilateral and muscle aches in both arms 1 day after vaccine. Improved with exercise-resolved 2/22/10.
Arm was soar/red/swollen at injection site and extended all the way below elbow. Could not lift arm above head for 3 days. Took ibuprofen for 4 days following administration to help with symptoms and sleep.
Information has been received from a physician concerning a 9 year old female patient with no past medical history who on 07/01/1998 was vaccinated subcutaneously in the right arm with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck) (lot#624778/1565E).  There was no concomitant medication.  On 04/11/2004 the patient experienced 25 chickenpox lesions and came into the office on 04/13/2004.  It was noted as breakthrough disease following exposure to a cousin with chickenpox.  No fever or complications were noted.  The patient was given diphenhydramine hydrochloride for itching and was sent home.  No lab tests were done.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20H and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Viral syndrome ((chronic-peak and viral syndromes)). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided were blood pressure medication nd antiviral drugs. Treatment medication provided were Tylenol.   Follow-up received on 5-May-2021 included no new information.   This case was linked to MOD-2021-037430 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up was received on 5-May-2021 with NNI.
I experienced some slight tingling in my left eye after I left from the site I received the vaccine from. I had waited my 15 minutes to make sure that I wouldn?t have an allergic reaction to it and felt fine but soon after I left I started to feel tingling around my eyes and was not sure if that was a sign of an allergic reaction to the vaccine? I did reach out to my family doctors office and was told that it could of been a slight reaction to it. I am concerned if I can still get my 2nd shot when I am available to receive it or if I should not with the feeling that I got.
Developed maculo erythematous rash over right arm- suggestive urticarial rash. Benadryl 12.5mg/5ml QID PRN. Prednisone 30mg with food x Sd.
Raised red bumps; Full body rash with intense itching; Full body rash with intense itching; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, gout, high cholesterol, high BP, glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications (11, not enough space to list all) within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021 at 14:00 on Tuesday, 8 days after vaccination, the patient experienced full body rash with intense itching and raised red bumps. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with hydroxyzine (pill) (MANUFACTURER UNKNOWN)/Permethrin Cream. The clinical outcome of full body rash with intense itching and raised red bumps was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 08/13/2021, in the afternoon, I called 911 with severe Vertigo, I was ambulanced to the hospital. I was treated in the emergency room and treated for two nights and released. I had two months of physical therapy.
She had a syncopal episode 10 minutes into vaccine administration. Reported history of syncopal episodes with injections. Vital signs checked and stable. She was passed out for approximately 2 minutes, woke up and was not post-ictal. 911 was called and medics came in to check on patient. She was stable. Refused and signed AMA form for hospital transport. We observed her for approximately 30 minutes and made full recovery. Left in stable condition, asymptomatic.
Pt was incidentally given a 4th dose of Hep A when not needed. Pt had already completed series on time with previous vaccine dates of Havrix being done 06/22/2015 and 01/08/2016  and incidentally had additional Havrix Hep A vaccine on record at another facility 06/26/2018 as well.
severe hives p/vax;prev full series 3yrs prior w/booster 2yrs ago;29NOV94 f/u;tx w/susprine & Duodezone & DPH;7OCT94 went to hosp treated w/Pred
Pt. here for first dose of pfizer vaccine. Requested to sit by aid post vaccination for anxiety. Pt. complaint of chest pain without difficulty breathing. EMS contacted and pt. cleared to finish  observation without incidence.
I experienced severe muscle pain in my back and legs. My muscles seized up and I had trouble walking for two weeks.
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 37-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 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:21 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 37.25 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 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. 20 vials from this batch were sent to the clinic.  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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 23-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
a raising heart rate; Headaches; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069f21a, 011j20a and 030l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Heart rate: increased (High) raising heart rate..         Concomitant medication was not provided.  Company Comment: This spontaneous case concerns a 32-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious event of heart rate increased and other associated expected, non-serious events. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetmol), unspecified dose and frequency, affording no relief of symptoms. The events had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 32-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious event of heart rate increased and other associated expected, non-serious events. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetmol), unspecified dose and frequency, affording no relief of symptoms. The events had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Headaches,  severe pain at the injection site, muscle pain, fatigue, diarrhea, swollen lymph nodes left arm
Covid shot and flu vaccine were given one inch apart in left arm. Currently having a long (approximately 6 inch by 4 inch) red, itchy, warm to touch, swelling rash. Pharmacy has told me it will last 48 hours. Doctor's office has said to take Benadryl despite also taking Zyrtec. I am filling this form out so that the CDC does not recommend both shots in the same arm. Because of this for me, I have no idea if the flu shot or the Covid 19 Moderna Updated Booster 18+ is the cause of my reaction. I have never had a flu shot do this, nor has any of the other 4 Covid Moderna shots and boosters I've received over the course of Covid 19 pandemic, so I can't go from past experience.
On 2/2/21, the patient started to show redness and swelling at the injection site and most of the upper arm. The redness occurred from the deltoid muscle to the elbow.  The nursing staff at the LTCF applied ice and monitored the patient's condition.  By 2/4/21, the reaction was improving and resolved by 2/8/21.  No additional medical attention was necessary.
This spontaneous report as received from an immunization nurse refers to 3 female patients of unknown age. The patients were vaccinated with first doses of GARDASIL (lot number unspecified) on an unknown date. But for their second dose, the 3 patients were administered CERVARIX (GSK, lot number unspecified). No concomitant medications were reported. No adverse reaction reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Begining July 04 pt began having foot pain, muscle and joint pain, headache, generalized malaise, groin rash, "ringworm", chills, "feverish", hot flushing with headaches, nausea, dizziness, difficulty breathing (heavy air), sore throat, raspy voice.  Pt. was seen at site clinic and diagnosed with heat related injury.  Pt. still has approximately 3 "migraine" headaches a month and continuous "plantar fascitis."
This spontaneous report was received from a Licensed practical Nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Between 03-NOV-2016 and 07-NOV-2016, the patients were vaccinated improperly stored ROTATEQ, 2 ml, lot number M004544, expiration date 18-OCT-2017, (frequency, route and anatomical location were not reported). Temperature of 48.9 Fahrenheit degrees, 45 minutes of time frame and there was a digital data logger involved. No previous temperature excursion was involved. No product quality complain was involved. At the time of reporting, no adverse effects were reported. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested.
Covid Arm 8 days after injection. Redness, swelling, tender and hot to touch
Post vax, the pt experienced hives, shortness of breath, and throat closing. Reportedly the pt was given epinephrine and taken to ER. The pt also experienced hypotension and was given Benadryl at ER as well.
Information has been received from a 70 year old female consumer with acid reflux who reported she received an injection of the ZOSTAVAX for "shingles" on 17Aug2012 and "right the next day she started to experience side effects, however, she is still experiencing a rashy and hot feeling on that arm. She mentioned she also started feeling a little wheezing. Concomitant medication included: omeprazole. The consumer refused to provide her health care professional information and mentioned that she will contact her health care professional." The patient did indicate that she had the vaccine administered at a pharmacy. It was reported the patient did not seek medical attention. Additional information has been requested.
pt recvd vax & 3 wks later exp joint aches & body aches; tx w/Naprosyn;
After a few days I experienced discomfort and what feels like inflammation in my left breast.  Discomfort (not pain) has lasted every day for 22 days.  Due to get second vaccine on Wed March 31st.
Pt complains of pain and swelling in right deltoid. Right deltoid site is red, slightly swollen and pt states it is painful to touch.  Pt has full range of motion in right shoulder without pain.
Insatiable hunger, sore injection area.  Hunger lasted for four days.  Soreness at injection site lasted about 12 hours
Developed Shingles 9-10 days post injection. Pain for several days and then the skin lesions. ? connection
digestive discomfort and heart burn; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on an unknown date as 1ST SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got the first dose of the vaccine and experienced digestive discomfort and heart burn. The outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected
pt recvd vax 11NOV92 & 8JUL93 tested neg for rubella IgG; No further details were provided;
vaccine was given in right arm and she obtained gout in her lower right leg down to her ankle. red, sore to the touch, painful.  She came back to the pharmacy and notified me of this on Tuesday 5-28-19
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 was not reported. Concomitant medication(s) in 2 weeks included: LEXAPRO; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details for COVID-19 treatment included PAXLOVID (Brand), and treatment start date was on 15Jul2022 and treatment stop date was on 20Jul2022. Patient experienced rebound with worse symptoms starting 3 days after medication completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, Headache, Myalgia, Fever, SkinRash, CoughWheeze, Rash & UrticariaPruritus & Narrative:
pt recvd vax; red body rash; PAR reported pt was tx in er;
Patient reports inability to use left arm due to pain and limited mobility since receiving her Moderna vaccine on January 11th, 2022.  Patient reported the vaccine administration was painful and thought the needle hit the bone.