chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My throat started to itch and swell within 10 minutes of receiving the shot. It did not close up enough to block the airway.; My throat started to itch and swell within 10 minutes of receiving the shot. It did not close up enough to block the airway.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non pregnant female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 02Apr2021 at 05:15 PM (age at vaccination was 42 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history includes allergies to barley & shellfish. Concomitant medications includes loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. On 02Apr2021 at 05:15 PM, the patient experienced her throat started to itch and swell within 10 minutes of receiving the shot. It did not close up enough to block the airway. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The report was non-serious. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
pt comes from the cove- diagnosed with covid 7/29/21. 84-year-old male presents to ED via EMS for change in responsiveness; diagnosed with COVID-19 virus on 7/29/2021. PMHx dementia, HLD, UTI. Reportedly, patient has been weak and sleepy, which is normal from his alert, talkative baseline. While in ED, patient was having respiratory difficulty which improved with NRB. Further history limited secondary to current clinical condition. No family at bedside. Patient was still admitted when form was submitted
Pt woke late PM 21DEC91 w/fever of 104 R; Had been taking APAP since vax recvd on 21DEC91; mom called MD & a prescription for advil was given; temp cont to run 102.2 until 22DEC91;
patient was complaining that she feels hot and has trouble to breath soon after I gave her moderna covid vaccine. Within  two minutes she start to collapse from the chair and I held her and let her lie down on her back on the floor and start administer epinephrine intramuscularly in the patient's leg at the same time I instruct my Tech to call 911 and to inform mgmt. of white code  after 5 mints I repeat a dose of epinephrine then after that the EMS arrived and took her to the hospital. I called her the  evening  on the same day to check how she is doing and she told me that she feels better but the hospital will keep her for observation for the night.
3/31/2021   Patient was observed post Covid-19 immunization for 60 minutes for symptoms of agitation and shortness of breath.  During the observation period, he experienced an adverse reaction with the following symptoms: per mother who is caregiver to son who is non- verbal with cognitive impairment- complaints of difficulty breathing and severe agitation.   Assessment : Time of assessment 1100 Tachycardia. Extreme agitation , Medical interpreter used, patient non-verbal , cognitively impaired, attempted VS - unable to achieve due to combativeness.    Actions taken:  VS attempted- HR- 108, RA O2 sats - 99%       Medications administered: No medication administered.   Disposition: 911 called and patient transported to hospital for extreme agitation , tachycardia and trouble breathing.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/31/2021 10:47 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533   NDC: 59267-1000-2          Electronically signed by RN at 3/31/2021 12:08 PM  Immunization on 3/31/2021   Detailed Report  Note shared with patient
It started with a lot of pain in the right arm from the vaccine, a lot of fatigue, a horrible headache that didn't go away with nothing, chills with a high fever. I only had a little water and cola, with cookies. I felt disgusted. Today March 6 I am still tired and without appetite. I still have a slight fever. I have taken Advil and switched to Tylenol, but the headache didn't go away with nothing. I feel a little better now 9:20 am 06/03/2021, but still feeling bad.
Local allergic reaction (5 cm). Pt given BENADRYL and TYLENOL. No wheeze, SOB or throat symptoms.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 DM 2 W RENAL MANIFESTATION
Information has been received from a manufacturer pregnancy registry via a registered nurse concerning an 18 year old female with pertinent medical history and drug reactions/allergies reported as none who in December 2006 was vaccinated with the first dose of Gardasil (lot #653736/0868F), 0.5 ml, IM. Concomitant therapy included MENACTRA. In February 2007, the patient was vaccinate with the second dose of Gardasil, 0.5 ml, IM. the nurse reported that the patient received 2 doses of Gardasil while she was pregnant. The patient stated that she did not know that she was pregnant. The patient received no prenatal care. The patient delivered a female infant with and estimated gestational age of 32-36 weeks on April 22 or 23, 2007. In April 2007 after delivery, the infant experienced seizures. The nurse reports that after delivery the infant was transferred to another hospital. After internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Patient received both the Fluzone HD and Arexvy on Saturday10/14/23.  Patient received both shots in his left arm.  Patient states that Saturday night he started to experience body aches and a low grade fever.  He said that he was lethargic all Sunday.  He stated that when he woke up Monday morning he had a rash on his left arm and his lip was swollen.  He said that he took a dose of xyzal and the itching and rash has calmed down and appears to be going away.  He stated that his lip is somewhat still swollen.  I told the patient he could also take Benadryl for the itching and swelling if needed.  I told him that if his condition worsens to go to the ER or his primary care provider.
Hx of febrile seizures and after received his DTap and MMRV he had another febrile seizure-the next day actually. EEG was nl.
Red hives, redness and inflammation at injection site, large bruise right by injection site that she said appeared immediately. Was not feeling well next day. Headache 2 days later.
itchy red, raised bumps started 13JAN97-cont erupt thru 18MAR97;looked like varicella by 17MAR97;fever 17MAR-19MAR @ least 21MAR97 almost all scabbed,
Swollen lymph nodes under arm; Sharp Pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 03:00 (Lot number: EW0172) at the age of 12 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD. Concomitant medication(s) included: GUANFACINE; CONCERTA. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19May2021, outcome "not recovered", described as "Swollen lymph nodes under arm"; PAIN (non-serious) with onset 19May2021, outcome "not recovered", described as "Sharp Pains". The events "swollen lymph nodes under arm" and "sharp pains" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The caller was calling in regard to her 12-year-old son who received his first dose of the vaccine and now has swollen lymph nodes. They visited urgent care today. Patient is having sharp pains and she is assuming it is from swollen lymph nodes under the arm. Caller states the pain and lymph nodes are getting worse. She thought maybe it' worse in the morning, can be sicker in the morning and walking around increases circulation and other stuff. Caller states patient woke up this morning and it was worse.  No follow-up attempts are possible. No further information is expected.
Ten minutes following administration of vaccine, patient verbalized feeling numbness of the tongue, being able to taste the vaccine and having sweaty hands. Vital signs taken and pt requested to take Benadryl 25mg. Pt able to swallow water and medication without difficulty. Symptoms improved in about 60 minutes and drove self home.
pt recv vax; 3jun94, exp rt external ear pain; sx persisted x 5 days; on 9jun94,exp fatigue which lasted for 24 hr;
Information has been received from  from GlaxoSmithkline (2001006335-1) concerning a 5 year old male who on 03/05/01 was vaccinated with MMRII. On approximately 03/06/01, 1-2 days later, the patient experienced baseball-sized redness, pain and heat at the injection site. Medical attention was sought. As of 03/08/01,the patient's redness, pain and heat at the injection size persisted. Follow up information from a registered nurse indicated that after review of the patient's chart and confirmed that the baseball-size redness, pain and heat at the injection site in this case were associated with DTP (manufacturer unknown) and not MMRII (MSD) (lot # not available). The information was originally received from a registered nurse.
From 07/22/2015 to 07/24/2015 Pain at vaccine site, chills, fever 102F, dry cough, diarrhea, vomiting, painful joints (all), severe headache, neck pain, arm pain, rashes, weakness, dizziness. From 07/25/2015 to 07/27/2015 headache and severe pain deep within the left arm where shot was administered, became more severe and unbearable. Unable to move left arm, not able to function, work or even type. Not able to sleep due to severe pain. Today 07/27/2015, I am still experiencing severe arm pain, unable to move it and neck and head pain on left side.
Inocmplete course of vaccination; DAPTACEL was received on 12/29/16 , INFANRIX on 12/30/19 and 8/24/21.; Inappropriate age at vaccine administration; dtap series DAPTACEL then INFANRIX; Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (DAPTACEL) for prophylaxis.   On 24th August 2021, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 30th December 2019, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 29th December 2016, the patient received DAPTACEL. On 30th December 2019, not applicable after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced interchange of vaccine products and inappropriate age at vaccine administration. On 24th August 2021, the patient experienced drug dose administration interval too long and inappropriate age at vaccine administration. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration, interchange of vaccine products, inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was unknown. The patient received DAPTACEL (other manufacturer ) and then received INFANRIX, which led to interchange of vaccine products and inappropriate age at vaccine administration. The patient received INFANRIX 2nd dose late which led to inappropriate age at vaccine administration and lengthening of vaccination schedule. The reporter asked if the 7 year old patient could compete the dtap series with boostrix. Till the time of reporting the patient did not complete vaccination series which led to incomplete course of vaccination. The reporter consented to follow up. No other information was available.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were  not reported. In July 2013 (reported as "3 years ago"), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported). Since an unknown date, the patient experienced a shingles outbreak every 6-8 weeks. It was  unknown if the pharmacist would be interested in varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR). The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
Patient given COVID vaccine at 11 years and 359 days (5 days short of his 12th birthday)
8/17/10 Received tetanus shot about 9:30 a.m. Experienced sharp pain in head on & off 4pm-8pm. Felt tired, warm, 11pm-8:30 am severe head pain on left side with body jerking. 8/18/10 - 8:30 a.m nurse request TYLENOL, liquids, rest. Thurs. 8/19/10 Intake TYLENOL (1,000mg) at 11:00 a.m every 4 hrs not to exceeds 8 tabs. Fri - 8/20/10 Intake TYLENOL at 8:am, 12pm, 4pm, 8pm pain persists through the night. Sat - 8/21/10 - 8:30-9:00 a.m Dr recommend 200mg of ibuprofen 3 hrs after taking TYLENOL as needed to help w/sleeping. 8/22/10 8:am TYLENOL, 10:am church, prayer, 4pm pain free. This was a "horrible" experience, I'm very upset about it.
Left arm redness and swelling worsening still after 7 days. With well defined margins suggestive of vaccine reaction vs cellulitis
bleeding a lot; losing a lot of blood; hemorrhoids; Blood Transfusion; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding a lot) and HAEMORRHAGE (losing a lot of blood) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HAEMORRHAGE (bleeding a lot) (seriousness criterion medically significant), HAEMORRHAGE (losing a lot of blood) (seriousness criterion medically significant), HAEMORRHOIDS (hemorrhoids) and TRANSFUSION (Blood Transfusion). At the time of the report, HAEMORRHAGE (bleeding a lot), HAEMORRHAGE (losing a lot of blood), HAEMORRHOIDS (hemorrhoids) and TRANSFUSION (Blood Transfusion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.  This case concerns a 21 year-old male patient with no reported medical history who experienced the unexpected serious event of hemorrhage. The event occurred approximately 4 months on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 21 year-old male patient with no reported medical history who experienced the unexpected serious event of hemorrhage. The event occurred approximately 4 months on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Thrush; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CANDIDA INFECTION (Thrush) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CANDIDA INFECTION (Thrush). At the time of the report, CANDIDA INFECTION (Thrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Injection site reaction, with redness, puffiness, and warm to the touch. Seen at Clinic in the store 10/11/19 at 6:30pm treating for possible cellulitis and referred to radiology for a Doppler scan to check for clot
Initial report received from a health care professional on 07 January 2010. A 62-year-old female patient with a medical history of hypothyroid, chronic fatigue (Lyme), and acne, had received a first dose intramuscular right deltoid injection of FLUZONE, lot number U3394AA and a first dose left deltoid intramuscular injection of PANDEMIC INFLUENZA VACCINE, lot number 101328 6p (invalid sanofi pasteur lot number, manufacturer unknown) on 14 December 2009 at 4:44PM, and immediately upon vaccination, she developed pain in her arms, neck, bone, muscle, tendons, neck to toes, soreness in her neck glands and a headache. She experienced additional symptoms (times to onset not reported) which included asthma, falling asleep during the day, she was emotional (on edge), felt hot all over (not hot flashes), experienced spatial disorientation - bumping into walls, and had an inability to stand (bed bound); memory, sleep (pain). According to the reporter, pain was still in her feet and hands, and worsened with exercise. It was reported that the patient was stressing over a car accident using a rental car; she was not driving (time of accident unspecified). The patient had no concurrent illness at the time of vaccination. She had been taking VALTREX, L-THYROXINE and topical hormones "E,P,T" concomitantly. The patient did not have a PCP (primary care provider) and at the time of the report she had not recovered. Documents held by sender: None.
pt recv  vax 11SEP96 & 16SEP96 pt exp a fever;
Chest pain, left arm pain, numbness. Pt transported to ED with ST changes. ST changes subsequently thought to be early repolarization variant and not MI.
Patient developed a 4x3 cm area of erythema & swelling on right thigh.
PT SAYS HE EXPERIENCED NORMAL VACCINE SORENESS, STARTING THE DAY OF VACCINE.  SORENESS TURNED TO PAIN, AND HAS BEEN GETTING PROGRESSIVELY WORSE OVER PAST FEW DAYS, RADIATING TO SHOULDER, NECK, AND ARM.  PT WAS ADVISED TO SEEK MEDICAL ATTENTION ASAP, AND TO CALL WITH ANY MORE QUESTIONS.  HE EXPECTS PHARMACY TO FOLLOW UP WITH HIM.
Day after shot:  Extreme headache began in AM;   around 3:30 PM:  experienced extreme fatigue,  unable to stay awake and achy feeling.  cold chills, unable to warm up even with blankets and sweatshirt slept until about 3:30 AM Episode seemed to be over by 3:30 AM
Initial unsolicited report received from a healthcare professional (patient's father) on 23-Feb-2018. This case involves a male patient (age not reported), who was vaccinated with FLUZONE QIV (batch number, expiry date, route, dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was just diagnosed with influenza (based only on symptoms). It was also reported that diagnosing facility had run out of throat swabs, so they could not swab him to be able to confirm the diagnosis via laboratory test, or provide type information. Other lab test and corrective treatment were not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: influenza. Documents held by sender: none.; Sender's Comments: Patient developed Influenza infection post vaccination. The exact time to onset is unknown. The boy was diagnosed with Influenza based only on symptoms without any confirmatory test for starin identification. This is a poorly document case as time to onset is unknown, additional information regarding patient medical history, infectious history and lab or serological confirmation are needed to confirm vaccination failure.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Chest tightness; onset about 1 hour after vaccine until 4 days post vaccination.   Swollen eyelids.; onset about 12 hours post vaccine until 2 days post vaccination.   Cough. Fever. Headache. Body aches/soreness. Sleepless. Nausea; onset about 12 hours post vaccine until 7 days post vaccination.  Cough and some chest tightness remain
Pts left leg from upper thigh down to the shin was red, swollen and hot to the touch.  The patient could not walk because of the pain from this.
This spontaneous report was received from a medical assistant concerning a 59 years old female patient. The patient's pertinent medical history included fibromyalgia, diabetes mellitus, high cholesterol and high blood pressure. On an unspecified date in January 2016, the patient was vaccinated with ZOSTAVAX, 19400 PFU (dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies included CYMBALTA. On an unspecified date in 2016 (reported as "a couple of weeks ago"), the patient was seen in an unspecified urgent care clinic because she "broke out with a case of shingles". The patient was prescribed VALTREX to treat the shingles. Additionally, since the shingles outbreak, the patient's fibromyalgia symptoms had increased (fibromyalgia worsened). No product quality complaint was involved. At the time of reporting, the outcome of the herpes zoster and the fibromyalgia worsened was unknown. The causal relationship between the herpes zoster and the fibromyalgia worsened with ZOSTAVAX was not provided. Additional information has been requested.
Left Shoulder pain and weakness leading to rotator cuff tendinopathy. This was addressed at our clinic initially on 2/8/21 and then on 3/3/21.