chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 28 year old female health care professional and consumer with a history of wart on her hands (2001/2002) who on 15-AUG-2006 was vaccinated with the first dose of Gardasil (lot # not reported). In October 2006 the patient was vaccinated with the second dose of Gardasil (lot # not reported). In January 2007 the patient was vaccinated with the third dose of Gardasil (lot # not reported). Concomitant therapy included vitamins (unspecified). In February 2007 "one month" after completion of the series the patient began experiencing warts on her hands. She had a history of warts on her hands but her last "outbreak" was 5 years prior to receiving Gardasil around 2001/2002. It was reported that she has been developing these warts on different spots on her hands from February 2007 to the present day. She also reported that she has to have these warts frozen and removed periodically. The warts were never tested (no biopsy) or etiology unknown. The patient has not recovered. Additional information has been requested. follow up 2/16/2010- follow up information received on 15-apr-2006. the patient, a white female weighing 235 pounds and height of 69 inches. on approximately march 2007 broke out with warts on her right and left hands about two months after her injection. patient has had "cryo" therapy on them several times. they re-occur in different spots each time. at the time of the report it was unknown if the patient had recovered. the lot number of all three vaccine given to the patient was 651650/0702f.
Patient reported about 6 hours after getting the vaccination starting with symptoms of chills, headache, body aches and flu like symptoms that lasted a full 24 hours until resolving.
Provider states low grade temperature (101F) the weekend following injections. Cellulitis roughly the size of palm with no abscess.
Administered to a 16 year old by mistake; Sore arm; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  sore arm.    The patient's medical history was not provided. Concomitant product use was not reported.  On 23 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient was 16 years of age when she was administered the mRNA-1273 vaccine by mistake. Additionally, the patient experienced a sore arm. No treatment information was provided.   The second dose of mRNA-1273 was discontinued in response to the events. It was reported the patient would be receiving Pfizer's COVID-19 vaccine as their second dose.   The outcome of the event, given vaccine to a 16-year-old by mistake, was considered resolved. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 16 year old female patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event of sore arm. There were no other reported adverse events after the vaccine was administered in this event of product administered to patient of inappropriate age. Patient cannot be contacted and no further queries are issued.
second shot on3/8/21 basically fine all day, 3/9/21 630am one hour and half felt slightly beat up then fine, an hour and half later same thing, and then 2pm same thing then fine. on 3/9/21 woke up with finger tips white and cold and arm cold and sweat from shoulders up,i then  got up and moving and was fine after that. dry spot in throat with occasional cough once and a while throuout the day, then friday night had sat down to dinner and had a 3 minute vomitting upset stomach (did not vomit), and then went away.  mother in law tested positive on 3/10/21 and wife tested positive on 3/13/21 so i went to test on 3/13/21 just to rule out and received positive result call from test site on 3/14/21 at 2pm.
PAIN ALL OVER ARM AND MOST OF BODY; HEADACHE; HOT HEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced pain all over arm and most of body, headache, and hot head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain all over arm and most of body, headache and hot head was not reported. This report was non-serious.
Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient).  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing;  her throat started to feel like it was closing up and her tongue was really thick.  She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away.  She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
After injection into thights, child began to hold breath and then had gernalized tonic/clonic seizure.  Squad was called and transported to ER.  Kept overnight for observation.
Patient came to ED with generalized weakness, chest congestion, cough, and some shortness of breath.  Patient tested positive for Covid and was admitted to the hospital and treated with remdesivir.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M021407, expiry date 30-APR-2018 (dose, route of administration and anatomical location were not specified). The administered dose of GARDASIL 9 was stored at 33.4 Fahrenheit degrees for 52 minutes. There was no previous temperature excursion. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter.
A few minutes after I had received the vaccine shot, I noticed a slight pain at the injection site, which lasted for about 48 hours.  I also noticed that my face was flushed and I experienced some light-headedness, which I reported to my care giver.  After being monitored for an hour with improved symptoms, I was discharged.  Subsequently, on April 8, 2021, I noticed pain, tenderness, slight redness, and itching at the injection site.  Contacted my caregiver and was told to take Benadryl and apply a cold compress to the site.  I also treated it with Cortaid.  Symptoms cleared up within 48 hours and have not recurred.
My menstrual cycle has been late for over two weeks. I?ve had no regular pms symptoms I usually get. It has been 45 days since my last period. I have a regular cycle and was supposed to get my period approximately September 1st.
Large bruising extending to L upper chest; lasting for 3 days following immunization. Patient report of chest pain
Some of the vaccine was leaked out; Some of the vaccine was leaked out; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Some of the vaccine was leaked out) and UNDERDOSE (Some of the vaccine was leaked out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Some of the vaccine was leaked out) and UNDERDOSE (Some of the vaccine was leaked out). On 24-Mar-2021, DEVICE CONNECTION ISSUE (Some of the vaccine was leaked out) and UNDERDOSE (Some of the vaccine was leaked out) had resolved. Not Provided      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 concomitant medications were reported.  No treatment information was provided.
Initially at 8pm on march 30th itching and inflamed size of quarter dollar, puffy and painful to slight touch. 12 hours later after anti-inflammatory medicine, inflammation decreased slowly over 12 hours and stayed pink/purple in color for 24 hours, fever ranging from 99.8-101.1 for total of 48 hours.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA, lot # M003025 with expiration date of 26-MAY-2017 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA002933: US-009507513-1702USA008022:
Pt  c/o severe pain and limited mobility in his right arm.  had temp 0f 102, general body aches and weakness.  there was minimal swelling at the site of injection.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a six months old female patient who was vaccinated with a 0.5 ml third dose of vaccine PENTACEL (lot C5408AB and Exp. Date 06-OCT-2019) via intramuscular route in the left thigh on 04-Dec-2018. The patients' medical history not reported and concomitant vaccinations included PREVNAR and Rotavirus Vaccine for Immunization on 04-Dec-2018. It was reported that, the patient was accidentally injected with the DTAP/IVP liquid portion of the dose to the patient, however did not mix in the powder portion of the ACTHIB portion of the injection. It was an actual medication error case due to inappropriate reconstitution technique. There was no Adverse event noted at the time of the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
The needle of the syringe had not been tight and  the vaccine was not administered into the pt but leaked out down the patient arm
CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA SHOCK, UNSPECIFIED 10/30/2022, 11/16/2022, 12/10/2022, -RECURRENCE OF SAME SYMPTOMS
tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from contactable consumer. This consumer reported similar events for two patients (wife and daughter). This is 1st of 2 reports and refers to reporter's wife.   A female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date (Lot number not provided) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 (Lot number not provided) as single dose  for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient has recently tested positive for COVID19. It was unknown if the patient received treatments for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446811 Same reporter/drug/event, different patient
Case number PHEH2014US007574 is an initial spontaneous report received from a consumer on 15 Apr 2014. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. On an unknown date in Nov 2013, she was vaccinated with a flu shot (manufacturer and batch number: not reported, hence conservatively coded to seasonal influenza vaccine). On an unspecified date in Feb 2014, after the vaccination, she experienced flu like symptoms. Following the event she was admitted in the hospital, where she underwent X-Ray. X-Ray confirmed pneumonia and then bronchitis. She was discharged from the hospital after three days. However after being discharged from the hospital, she did not feel better and was again hospitalized on an unspecified date. She was then diagnosed with flu despite the vaccination and stayed in the hospital for five days. She had completely recovered from the events on an unknown date in Mar 2014. The causality of the events was not reported.
legs are so sore; So much pain; Tired; Muscles sore; Woozy; Didn't have balance; Barely got to bathroom; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Woozy), BALANCE DISORDER (Didn't have balance), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Barely got to bathroom), PAIN IN EXTREMITY (legs are so sore) and PAIN (So much pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Woozy), BALANCE DISORDER (Didn't have balance), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Barely got to bathroom), FATIGUE (Tired) and MYALGIA (Muscles sore). On an unknown date, the patient experienced PAIN IN EXTREMITY (legs are so sore) and PAIN (So much pain). At the time of the report, DIZZINESS (Woozy), BALANCE DISORDER (Didn't have balance), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Barely got to bathroom), PAIN IN EXTREMITY (legs are so sore), PAIN (So much pain), FATIGUE (Tired) and MYALGIA (Muscles sore) outcome was unknown.            No concomitant products information is provided  No treatment products information is provided
Around 3:30pm the day after injection I felt queazy with  stomach tightness.  Tested blood sugar.  It was 78.--technically not dangerously low but low for me.  Drank a non-diet Sprite.  Physical discomfort went away.  Felt tired.  Fell asleep for 2-3 hours.  After officially going to bed I woke up approx 2:30am feeling light-headed and shakey which is typical reaction when my blood sugar is too low.  Tested blood sugar.  It was 54.  Ate 7 life saver candies and went back to bed.  The next day (second day after injection) around 3:30pm felt hot which is  another typical reaction when my blood sugar is low.  Didn't test blood sugar but ate 7 life saver candies.  Then I felt better and continued on with my day.
13 year old kid was given Fluzone Quadrivalent subcutaneously instead of intramuscular, no AE.; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a physician (doctor).  This case involves a 13 years old patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date and other dosing details not reported) via subcutaneous route in unknown administration site.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination (PT: incorrect route of product administration).  No adverse event reported at the time of reporting.  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 Directive and Module VI of the Practices. 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.  Information on batch number was requested.
No adverse events.  We were instructed to report because vaccine was given to patient under 18 years old.
Fever; Chills; She developed a "weird" taste in her mouth; Loss of appetite; This is a spontaneous report from a non-contactable consumer (patient sister in law) via Pfizer sales representative. A 57-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at second single dose for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 for COVID-19 immunization (1st injection). The reporter was made aware this morning that the patient received the vaccine booster shot (2nd injection) of Pfizer's COVID-19 vaccine yesterday morning (06Jan2021). After receiving the vaccine she experienced a mild fever and chills overnight which were now resolved. Furthermore, after the fever/chills resolved, she developed a "weird" taste in her mouth and loss of appetite but overall doing well. Despite the events she continued to perform her duties as an anesthesiologist today. Outcome of the event fever and chills was recovered, of events "weird" taste and loss of appetite was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID?19 Vaccine EUA  Local rash, itching, raised. Vaccine site urticaria?
Muscle pain in left shoulder where received vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 07Mar2021 (Lot number: EN6199) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart attack", start date: Mar2020 (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "dual hearing aid" (unspecified if ongoing); "Hearing disability" (unspecified if ongoing); "allergy to iodine" (unspecified if ongoing), notes: allergy to the iodine in shellfish, makes his skin swell and itch; "anaphylactic reaction " (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement (ongoing). The following information was reported: MYALGIA (non-serious) with onset 07Mar2021, outcome "recovered" (07Mar2021), described as "Muscle pain in left shoulder where received vaccine".  Additional information: The patient took a bunch of heart medications. Clinical course: Patient had muscle pain in his left shoulder where he received the first dose Pfizer COVID-19 Vaccine. The muscle pain in the left shoulder lasted for two hours and that went away.   No follow-up attempts are possible. No further information is expected.
10 or more loose stools per day x's 1 week so far. Given Pedialyte & put on ISOMIL DF formula.
Can't get out of bed; Can barely walk her dog; Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Sick"; BEDRIDDEN (non-serious), outcome "unknown", described as "Can't get out of bed"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can barely walk her dog".  Additional information: It was reported as, the patient wanted to speak with the legal department because she got a lawyer and they're going to start something because she said that we saved thousands and millions of lives but we also infected people. She doesn't have diabetes, heart disease, or HIV and she is a normal person and very healthy. She mentioned that we ruined her life and that she was a medical reporter. Afterwards, she wanted to speak to the president of Pfizer to settle these things out.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu vaccine given left deltoid. 15 minutes later, patient complained of left shoulder - red rash noted on back and shoulder. Emergency protocol followed. Benadryl PO per MD ordered. Ice applied.
Info has been received from a physician, via a company representative, concerning a 98 year old male who "two years ago", on 4/26/04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. "Two weeks ago" on 4/26/06, the pt died due to non-pneumococcal cause. It was reported that the pt was hospitalized or had prolonged hospitalization and that the experience was life threatening. The non-pneumococcal cause of death was considered to be immediately life-threatening. Additional info has been requested.