chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nose becomes very itchy; Have thousands of sneeze, uncontrollable sneezes.; Feel a little of itchy eyes; Couldn't sleep well at night because of the itchy nose; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 at 09:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. 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 vaccination. Concomitant medications were not reported. On 22Apr2021, the patient's nose became very itchy and had thousands of sneezes, uncontrollable sneezes. The patient also felt a little of itchy eyes and couldn't sleep well at night because of the itchy nose. The patient never had any allergic reaction in life before. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nose became very itchy, thousands of sneeze uncontrollable sneezes, itchy eyes and couldn't sleep well at night because of the itchy nose was not recovered at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
No symptoms until 48 hours post injection. Patient presented with redness, swelling, fever, and a knot at injection site. Patient complains of itching and soreness at injection site which have improved over time. Patient spoke with PCP who agreed with our recommendation of a cold compress and antihistamine treatment for symptoms.
Per Mom - fever 104 degrees -seizure - stopped breathing - called 911 - EMS came did not take to ER.
Slight arm pain following vaccine same day but next day I had high fever, chills, fatigue, nausea, muscle  pains, and a migraine that debilitated me completely.
Rash / hives on hands and wrist starting 30 minutes after vaccination. Started on left hand & wrist first (side that vaccine was given on). More severe on left hand & wrist than right hand & wrist. Also felt feverish starting 30 minutes after vaccination.   As of 5 hours after vaccination, rash is less severe but still present. Feverish feeling still present. Mild GI upset (diarrhea, gas). Slightly fatigued.
Six days after receiving the first dose of the Moderna COVID-19 vaccine, the site of the injection began intensely itching. A patch about 6 inches long and 4 inches wide around the injection site became red, a little bumpy and hot to the touch. The itch and redness intensified over the next two days, which is now seven and eight days post injection. The itch is non-stop; the redness has spread and it's still warm to the touch. On the ninth day post-injection, the itch has subsided, the warmth is gone and the redness has started to go away. By the tenth and eleventh day post-injection, all symptoms have subsided.  I am scheduled for the second dose Jan. 25 and plan to get it in my left arm and will monitor to see if I get the same results.
Patient states she took a home pregnancy test on 8/18/13 and states it was positive during 8/19/13 office visit.
PATIENT WAS ADMINISTERED FLUAD IN THE LEFT ARM AND BOOSTRIX ON THE RIGHT ARM. HE STATES IT WAS HIGH AND AT AN ANGLE. HE SAID AS SOON AS HE FELT IT GO INTO THE ARM, IT HURT. HE WENT TO URGENT CARE TO RECEIVE CARE ON 8/20/19. THEY TOLD HIM TO GIVE IT ANOTHER WEEK. HE WAITED AND FELT NO IMPROVEMENT. HE WENT TO HIS PRIMARY CARE DOCTOR. PCP SUGGESTED IT WAS ADMINISTERED INCORRECTLY.
I started having cardiac pauses in August 2022, three months after having test positive CoViD infection.  At a routing cardiology check-up 10/20/22 my doctor set me up for 30 day wearble monitoring, starting 11/2/22.   On 11/08/22 my doctor called me that the monitoring company had reported something to him that I needed to  talk with him about.  I saw him 11/10/22 where he described two 9 second pauses had occurred at 0500 on 11/8/22.   He recommended a permanent pacemaker be instituted ASAP..  I was admitted  to the hospital that afternoon to await pacemaker.  That night I had many symptomatic pauses.  The pacemaker was installed the evening of 11/11/22.
For five days after the vaccine, the skin in and around my mouth was so sensitive that it would slough off at just a touch of my tongue. The issue went away on it's own.
Shingles vaccine given at the same time as TDAP.  Experienced headache, fever, chills, muscle pain, and joint pain.
Swelling under (R) arm - resolved w/in 3 days. Pt. had been cutting grass the same day. Symptoms occurred 6 days after injection.
pt devel irritability approx 1 hr p/given; fever to 101; 2-3 hrs p/pt convulsing w/tonic-clonic activity & fever to 105.8 (ear); occurred approx 7 hrs p/vax;
21.5 weeks pregnant, first pregnancy. Due date 6/24/21.  Day of injection (Monday): strong deltoid soreness. Day 1 following injection (Tuesday): upset stomach. Far less fetal movements than usual throughout most of the day. Day 2 following injection: sore throat that come on in the evening. Quickly spread into lymph node pain in neck, up through the back of the throat toward the nasal cavity, inner ears and behind the eyes. Fetal movement increased to what has been typical at this stage of pregnancy. Day 3 following injection: sore throat, fatigue that was worse when sitting stationary, dizziness, headache. Pain improved in throat, sinuses and behind eyes in afternoon then returned in the evening.
Patient seen in ER on 5/21/21 due to chest pain that was diagnosed as pericarditis, patient with continued chest pain on in clinic visit on 5/26/21 in PCP office. Patient was sent back to ER for new nature of chest pain, and given ibuprofen.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 09/03/2021 and 04/06/2021. They presented to emergency department on 11/10/2021 after about a week of "cold-like symptoms." Primary complaint was respiratory distress, with oxygen levels 80% or lower on their normal 4 L of oxygen. They were admitted to hospital and required intubation. Intubation did not raise oxygen level above 70%. The individual was re-intubated but this also did not raise oxygen level. Decision was made to transfer to a different hospital for higher level of care via air ambulance.  Pulse was lost during flight. CPR initiated and continued for about an  hour after arrival at the destination hospital. Pulse was recovered, but prognosis was poor to due length of time of low oxygen levels. Family opted to discontinue aggressive measures and the individual died on 11/11/2021.
site of injection red and raised day 1, site of injection warm & very sore day 2, it seemed to improve and on day 9 site of injection is warm, round red raised circle.
Increased fatigue, chills, fever, soreness, rash and blisters broke out on lips, tongue and nostrils; sinus trouble and pain, injection site redness and soreness. (FAMVIR 500 mg TID X 5 days).
PSA increased from 1 to 5 after first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of psa increased in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced psa increased. On an unknown date, the outcome of the psa increased was unknown.   It was unknown if the reporter considered the psa increased to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient had increase in prostate specific antigen from 1 to 5. The reporter consented to follow up.      Lab Comments: Laboratory test was done on an unspecified day
Information has been received from a physician concerning a 7 year old female who in September 1997, was vaccinated with a dose of varicella virus vaccine live.  In February 2001, the patient experienced full clinical varicella.  No prescription drug treatment was required.  Subsequently, the patient recovered.  Additional information has been requested.
Titres were were found to be positive for measles and rubella, but negative for mumps; This spontaneous report as received from a nurse refers to a currently 24-year-old female patient. The patient had no pertinent medical history. Her concurrent conditions included allergy to amoxicillin (+) clavulanate potassium (AUGMENTIN). The patient's concomitant medications included venlafaxine.   On 17-JAN-1996 and 12-JAN-2000, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously, doses and lot #s were not reported. On unknown date, titres were drawn and were found to be positive for measles and rubella, but negative for mumps. Another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered on 22-APR-2019, albumin status rHA, lot # R031628, expiry date 01-NOV-2020 via subcutaneous route. There was reported that the patient sought medical attention by consulting physician. The outcome of mumps antibody test negative was reported as not recovered. The causality assessment was not provided.
Pt was given 0.2mL of the 12+ Covid19 Pfizer-BioNTech vaccine instead of 0.2mL of the 5-11yr Pfizer-BioNTech vaccine.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N027000, expiry date: 28-SEP-2019) for prophylaxis. It was unknown if sterile diluent (dose, frequency, lot #, expiry date, route and indication were not reported) used for reconstitution of VARIVAX was properly stored. The vaccines were stored in temperature of 6 degree Fahrenheit (F) to 14 F for 5 hours 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.
A physician reported that his 6 year old son received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/02/03, and 5 days later, his son developed flu-like symptoms.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/02/03.  Dose regimen was 1 dose.  Pt was not taking concomitant therapy.  On 12/07/03, 5 days post-immunization, the child developed flu-like symptoms characterized by cough, stuffy nose and unconfirmed fever.  The physician reported that the child's 8 year old brother received Flumist on the same date and has no flu symptoms.  In 12/03, a nasal swab was positive for influenza.  No additional information was available at the time of this report.
11/11/2022 Vaccine was given, documentation states Bivalent was given, On covid-19 vaccination card record it is written LOT#FT1551  Pfizer was given. To be sure incident  report was made.  no actual harm to patient was done
Patient reported experiencing wide-spread redness and tenderness over entire upper left arm shortly after immunization.  She presented to pharmacy one week later with an approximately half-dollar sized red raised area around the site of the injection, which she had noticed within that day.  She reported that it was slightly itchy occasionally.  She was advised by us to see her doctor if the skin reaction worsened, or did not begin to improve within the next day or two.
Lot of fatigue; temperature for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lot of fatigue) and PYREXIA (temperature for a day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Lot of fatigue) and PYREXIA (temperature for a day). On 24-Feb-2021, PYREXIA (temperature for a day) outcome was unknown. At the time of the report, FATIGUE (Lot of fatigue) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.
Rash and swelling at injection site the next AM following injection. Child refused to walk x 2 days. Rash developed serpiginous border by 5 days post vaccination concerning for E.Multiforme type reaction.
Swelling of external ear and rash to torso approx 2 hours after vaccines. Hives vs. papular appearance. BENADRYL given.
Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced swollen lymph nodes in neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph nodes in neck was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had a runny nose and a cough but this is not unusual for me this time of year, my wife however, did test positive for COVID-19, this prompted me to test as well. I began testing on 12/06/2022 and tested daily until 12/10/2022 at 2AM I tested positive for the COVID-19 virus. I took PAXLOVID and I have recovered from the COVID-19 virus and back to my normal self.
Extreme increase in blood glucose despite pump therapy that adjusts to rises in blood glucose lasting for 4 days occurred shortly after vaccine despite not eating.  Nausea and diarrhea beginning about 7 hours after vaccine and lasting for 6 days.  Extreme burning in bones and pain and some swelling in joints.  Feeling of being tired continuing through report date.
After 73.75 years with no signs or symptoms of eczema anywhere on my body, approximately 2 weeks after my second Moderna Covid 19 vaccination I began breaking out in very itchy areas on my body. These areas were almost solely where I couldn't see them but only scratch them. I originally thought "bed bugs" and later blamed them on mosquito bites. As the areas increased in size and locations, I finally sought medical advise.
extreme soreness in her left arm; flu like symptoms; sore throat; headache; very lethargic; muscle aches; arthritis; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2020, the patient received the 1st dose of Shingrix. On 6th September 2020, 2 hrs after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis to be related to Shingrix.  Additional details were provided as follows: The patient received the first Shingrix injection and two hours later experienced extreme soreness in her left arm, she also developed flu like symptoms including a sore throat, headache, muscle aches were she has arthritis and feels very lethargic.  She has been taking Tylenol to relieve the symptoms but when the tylenol wears off the symptoms come back.  The symptoms were not resolved. The reporter did not consent to follow up.
PATIENT REPORTED SWELLING, HEAT, AND REDNESS FROM SHOULDER TO ELBOW. ON 8/31/16 SHE SAID SHE COULD BARELY LIFT ARM.
Medical evaluator reports:  profuse sweating, delayed response, near syncopal. EMS reports:  Pt feeling dizzy with Blurred vision after receiving shot.
J96.92 HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/7/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE
The thumb of right hand started aching. Woke me up during the night, too. By morning (10/24/2019), hand was swollen, especially area above thumb, which was also red and raised. Using fingers or thumbs was extremely painful. Lasted all day; a bit better by 10 PM. Next morning, pain much less but still achy; able to use hand again. Still red above thumb; finger swelling less by 2 PM. This happened with the first dose of Shingrix on 7-25-2019, with symptoms beginning 7-27-19. Then I had the vaccine in my left arm and problems began in my left hand, especially the thumb. I saw a doctor for that one at the walkin clinic on 7-29-19; I told her I thought it was the Shingrix causing it. She had me x-ray it anyway, which showed no problem. I purposely had the 2nd dose in my right arm, to see if it would cause the problem on that side or whether it had been a coincidence caused by something else. No coincidence! I anticipate that my hand will slowly return to normal, as happened in July. I decided to report this, since it is not listed as a possible side effect in any literature I've read. (I used to conduct research studies using medications, so I know how important this is). This first vaccine was also made by glaxo-smith-kline, Lot # B5HP5.
Employee was administered Afluria vaccine at 2:55pm and reported that she had itching to vaccine site, back, both shoulders and head immediately. Denied any other signs and symptoms.
This spontaneous report was received from a nurse refers to currently 4-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 19-FEB-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used.  Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. Vial did not undergo temperature excursion.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Followup was received, additional reporter was added.
Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 26Mar2021 at 14:00 as single dose (at the age of 46 years) for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient had no known allergies. Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 01:00, the patient experienced nausea, dizziness and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nausea, dizziness and headache was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm is a little sore) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm is a little sore). At the time of the report, MYALGIA (arm is a little sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. No treatment information was provided.
Started with tingling hands and feet that night, over past 6 days the tingling has continued in addition to twinges in legs, pain in back, sore thigh.  Tingling radiates from one area to another.  Both sides of body.  Went to primary doctor 11/9 and 11/11.  Went to neurologist 11/12.  Neurolgist exam showed normal strength and reflexes.  Told to "wait it out".