chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 20 minutes after receiving vaccine, experienced feeling like her head was heavy with slight trouble swallowing. Vitals: BP 160/90, pulse 105, SpO2 100. Patient requested a diphenhydramine, 25 mg. After ten minutes, patient's eyes were becoming itchy and red. Patient requested a second diphenhydramine, 25 mg. given. After 10 minutes, was feeling better and requested to leave. Vitals: BP 140/96, pulse 100, Pulse Ox 100. Discharge with father driving, advised to monitor symptoms and contact MD, or go to Urgent Care or ED if worsen.  Advised to follow up with MD for recommendations to proceed with 2nd vaccine.
Twenty minutes after injection broke out in a sweat from head to toe.  Vitals were only slightly elevated.    Continued with bouts or waves of warmth for 2weeks.  Also feel anxiety in my chest that continues
First dose 02Nov2020 / Second dose 07Dec2020; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th December 2020, the patient received the 2nd dose of Shingrix. On 7th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The reporter consent to follow up.
Case number PHEH2012US016501 is an initial spontaneous report received from a medical assistant on 20 Aug 2012, and with a follow up received on 04 Sep 2012: This case refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) intramuscularly into the right arm along with BOOSTRIX (batch number: AC52BOB5AA, manufacturer unknown) intramuscularly into the right arm on 17 Aug 2012. The medical assistant reported that within 48 hours after vaccination she experienced symptoms of swelling, 5 cm redness, warmth and tenderness at vaccination site. The final outcome of the events was recovered. No further information about the seriousness and causality of the event was reported. Follow up reported received on 04 Sep 2012: Updated batch number and vaccination site of vaccines. Events added.
I started with a high fever for 2 days and then out of nowhere I had diarrhea. I went to the doctor, and they ran all kinds of test, and they turned up negative. So, I had to go the emergency room. They did a CT scan which was negative. Then, they sent me to gastroenterology, and they did a colonoscopy. They did a biopsy, and it came back that I had lymphocytic colitis. I have lost 23 pounds and unable to keep any nutrition.  I was started on budesonide, and I too that until 9/14/22. This new diagnosis will be with me the rest of my life. It is not curable.
Hour 1 - elevated resting heart rate (110) Hour 4-6  - elevated resting heart rate (110), headache Hour 6-18 - elevated resting heart rate (110), headache, extreme fatigue, chills, body aches, fever (101), cyanosis Hour 18-48 - headache, extreme fatigue, body aches  It has been one week and I am still feeling very run down, tired, and body aches.
tested positive for Covid 19 virus; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0162) via an unspecified route of administration, administered in Arm Right on 17Apr2021 17:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Apr2021. The reporter has a question about her mother-in-law. Her mother-in-law received her first dose of the Covid 19 vaccine on 17Apr2021 but then tested positive for the Covid 19 virus about 10 days ago. Her mother-in-law's second Covid 19 vaccine is scheduled for Saturday, 08May2021. She was asking if her mother-in-law can get her second dose or if she needs to wait. The patient had the Covid 19 virus test on 21Apr2021 at an urgent care. She reports that some people say if her mother-in-law has had the Covid 19 virus she'll have worse symptoms with the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
In observation area, my tongue swelled up - nurse held be back for a bit to observe and gave me bottled water.  The injection site arm went dead and unable to move (left arm stated on my vaccination card but it was the RIGHT arm that was jabbed. Another inconsistency of this whole process).  I had weird tingliness shooting up to my neck/back of neck. After finally being released from the observation area when the tongue swelling went down, I was tired walking to my car.  That night I was exhausted and couldn't get off the couch and nauseated. The nausea and fatigue hit in waves over the next day.  On Monday (second morning after the shot), I could not get out of bed.  After finally getting up, I went to work. At work I was still dealing with fatigued, shortness of breath, my head was dizzy and light, then mid-morning I had sharp stabbing chest pains under my left breast, the pain shot up to my left neck and jaw. I could not breathe. The more I tried to breathe, the sharper my chest pains became. I had emailed my primary care doctor twice that morning because of symptoms and never heard back so when the chest pains hit, I went to the ER. At the ER they ran EKG, blood work, XRays. Kept me all day. At the end, they told me  I was healthy and let me go. The doctor had ZERO regard or interest in the fact that all of this started after the vaccine. No where in my notes was it noted that I had the vaccine.  The nurses told me this was a trend with the patients coming into ER complaining of post-vaccine symptoms and not having them documented.  I had breathing issues for almost two weeks after the vaccine where I would be short of breath and winded, not able to complete sentences without stopping for air.  I still have awkward breathing moments.  I called healthcare facility nightly to report this and again was told to just monitor my symptoms. I feel like this whole process has been an isolating, careless time where my vaccine side effects have NOT been taken seriously.
Large local reaction on R upper arm warm to touch covered upper 1/2 of arm. Given Augmentin 500 mg PO 1 tam Bid cool compresses. Questionable Cellulitis.
The patient developed a red rash and soreness at the injection site 2 weeks after the injection.
Drug ineffective; Contracted Covid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9269), on 01Mar2021 as dose 2, single (Lot number: EN6203) and on 23Aug2021 as dose 3 (booster), single (Lot number: EW0180) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stomach ulcers" (unspecified if ongoing); "seizure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastric ulcer; KEPPRA XR taken for seizure; EZETIMIBE taken for blood cholesterol decreased. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Contracted Covid after vaccination". The patient underwent the following laboratory tests and procedures: Endoscopy: (unspecified date) Unknown results, notes: he didn't see anything in the endoscopy, but there's a lot of stomach area in there; SARS-CoV-2 test: (15May2022) positive, notes: Tested positive for Covid on 15May2022; (23May2022) negative, notes: Tested negative for Covid on 23May2022.
Patient got very pale and passed out for about 2 seconds two different times, about a minute apart. Patient complained of dizziness and tinnitus and shortness of breath.  It did not appear the patient was having an allergic reaction. There was no chest tightness or throat or tongue swelling. I gave the patient a cold compress and put it on her forehead. Her parents were present and holding her hands and talking to her. The patient was sitting at the time of vaccine administration. After the patient awakened, I put her feet up on a chair.  I also gave her a little water to sip. The patient's mother called her dr's office and left a message for the nurse. The patient was still complaining of dizziness and was pale. The pharmacy technician who was also in the room went to call 911 and I called the manager in charge of the store. Then the patient's nurse called the patient's mother back and told her to take the patient to the hospital. The nurse was told that EMS was already on their way.  Approximately 3 to 4 minutes later, EMS arrived. The patient was awake that whole time and her parents were talking to her. I then left the room because it was a little crowded. The EMS team then put her on the stretcher and took her out of the store.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 13:00 as dose 1, single (Lot number: ER8732), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8727), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: Ff8841) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to animals" (unspecified if ongoing); "Allergy to dust" (unspecified if ongoing); "Allergy to mold" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "childhood allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Jan2023 to 25Jan2023,
Pt developed hives all over body. Approximately more prominent around DTaP site. No distress.
Very Sore Body for 36 hours after shot. Red swollen arm on 8th day after 1st shot very red, hot and mildly itchy
Hospitalization with COVID-19 infection after 3 doses of COVID-19 vaccination. Patient had Pfizer COVID-19 vaccinations on 3/3/21, 3/26/21 and 8/25/21.
Case previously recorded as MA2009-4342. Initial case report received from a health care professional via agency, on 17 NOV 2009. An infant patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. unknown) i.m. on 16 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008279.
status epilepticus & fever of unk origin;pt given med;CT showed cerebral edema;encephalitis;sz started 10 days p/vax;pt recv Acyclovir to cover possibility of herpes encephalitis;
I had a miscarriage and they estimated the baby died at 16 weeks 5 days.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 14:00 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included allergies penicillin and COVID-19. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) within 2 weeks of vaccination. Last menstrual period (LMP) was reported as 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 06May2021 16:00, the patient had a miscarriage and they estimated the baby died at 16 weeks 5 days. There were no genetic disorders detected, so the cause was unknown. Patient thought maybe the vaccine could have something to do with it. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included fetal demise removal. Outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Mother presented in clinic with child on 11/2/07 at 8:30AM.  Stated child had a reaction to vaccine given the previous week on 10/25/07.  After reviewing the chart, it was determined that she received three immunizations (DTaP, IPV, and MMR)on 10/25/07. Mother states on the day that the child received her immunizations she ran a slight temp and child complained that her arms were sore but had no further problems until this morning when she noticed a rash.  Child did not have a fever this am. Upon assessment a sporadic (diffuse) rash was noted on child's arms, legs, face, abdomen, and back.  Rash is described as red, raised, and is not itchy.  Mother states that child has not had any new foods or a change in soaps.  Mother instructed to follow-up with a physician. 11/2/2007 at 4pm:  Telephone call placed to follow-up on child's condition.  Spoke with father who stated that they gave the child benadryl and at this time the rash is almost gone.Parents are not going to follow-up with MD unless symptoms persist or get worse. Subsequent to conversation with father, child's mother phoned and stated that she had taken child into emergency room on 11/5/07 around 6:30pm for continued rash and fever of 102 degrees.  Child tested for strep throat-tested negative.  Per mother, MD believes child experienced reaction to one of the vaccines.  Steroid injection given in ER for treatment of rash.  Mother instructed by ER MD to continue with benadryl and tylenol as needed and follow-up with primary care provider. Per mother today (11/6/07) child has a low-grade fever of 99 degrees and rash is clearing up. 11/07/2007:  Follow-up phone call placed to mother who states that rash seems to be returning. Community resources for privated MD follow-up provided to mother.  11/08/2007pm:  Phone call to mother who states that child is doing much better.  No fever and rash nearly gone. 11/13/07 pm:  Phone call yielded report from mother that rash is completely gone and child is back to normal self.
This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (dose, frequency and route were not reported) lot # M047658 with expiration date of 28-OCT-2017, for prophylaxis. The temperature of the VAQTA was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003150: US-009507513-1705USA003154: US-009507513-1705USA003158:
Continual headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant 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 left arm on 16Jun2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia, hypothyroidism, polycystic ovaries, pseudotumor cerebri and COVID-19. The patient had unspecified allergies. The patient received unspecified concomitant medications within two weeks of the COVID vaccine. Prior to the vaccination, the patient was 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 four weeks prior to the COVID vaccine. On 16Jun2021, at 15:00, the patient experienced continual headache and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain medication and rest. The clinical outcome of the events continual headache and fatigue was not recovered at the time of this report.      The batch number for BNT162b2 was not provided and will be requested during follow up.
Shingles along the left jawline; mild rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th October 2022) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th October 2020, 54 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The patient developed mild rash developed. The patient also developed shingles along the left jawline after receiving the 1st dose of Shingrix. The reporter consented to follow up.
Patient returned to pharmacy, shaved vaccinated arm and her arm was very inflamed and red with a few red sores on the area, but about 4 inches below the injection site. The injection site is not affected. It appears to have only affected lower arm. Went to MD who presented Cephalexin and BENADRYL.
a small bruise; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins.  The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot.  The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Dark raised rash (in the shape of the cloth bandaid). Hurts if rubbed or touched. No fever, etc.
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat.  Also, broke my knee cap 2 years ago and it had become painful
Patient had no adverse symptoms while at the vaccine clinic. She called the vaccine clinic at 2:38pm and stated after she got back to work her lips "felt funny" . That symptom resolved but then she started itching all over her body. I recommended she consult with the pharmacist in the retail pharmacy where she works ( an afilliate of SBMC) to ask about an over the counter medication that would help with her symptoms given she is on other medication .
In the evening of patient's vaccines, we noticed that patient's skin had become red and raised in the area surrounding his vaccines - specifically on his Right thigh, but also to a lesser degree on his left. This rash continued to expand and worsen in the days to follow, getting red raised bumps that extended in a roughly circular area 8 inches in diameter beyond his vaccine site. The red bumps worsened in the presence of warm water. We applied Aveeno lotion to try to calm skin, minimizing bath times. One month following the vaccine, we took a photo of his continued rash - still worse on his Right thigh, but also present on his Left. It was red, itchy, raised with pimple-like bumps (they didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by this time, but stopped increasing). Now, nearly 5 months post-vaccine, patient continues to have a dry patchy skin in the area around his vaccine site on both legs. His Right leg (the more severe reaction) is now about 4 inches in diameter, the bumps are gone but the redness, raised, dry, itchy skin persists. Aveeno provides relief from the dry itch, but does not take the redness or raised skin away. I've reported this to Dr. and he asked that I file a formal report of the incident here. I'm indicating that patient has recovered (below) - his symptoms are improving, though not gone.