chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jun2021 12:30 (Lot number and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, known allergies included Wheat, gluten, wasp, yellow jacket and bee venom. Concomitant medication included gabapentin taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; cefixime (FLEXERIL [CEFIXIME]) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took high doses of prednisone and experienced drug allergy. The patient did not receive other vaccine in four weeks. The patient did not receive covid prior vaccination. The patient experienced after 5 minutes of injection, nasal passages congested and throat tightening and swelling. on 27Jun2021 12:35. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Aug2021. Therapeutic measures were taken as a result of after 5 minutes of injection, nasal passages congested and throat tightening and swelling and treatment included benadryl, claritin, albuterol inhaler, water. The events resulted in Doctor's office/urgent care. The outcome of the events was reported as resolved on an unspecified date in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Immediately after administering the vaccine, pt became pale, dizzy, and felt he was going to pass out. Pt was moved to floor and legs elevated. BP dropped to 84/49 with a pulse of 103. Provider was called to the immunization clinic and pt was evaluated. After 15 minutes BP stabilized at 105/62. Pt was moved to a sitting position and was given a drink of water and some cookies. After 15 more minutes of observation, Pt continued to improve. BP remained stable at with a BP at 104/66. Pt denied further dizziness and color returned to face.
really bad headache for 3 days and muscle and joint pain, fever and chills that lasted from Friday to Monday morning.
We don't know what happened. 25 hours after the shot, he started gagging and stopped breathing. He was pronounced at OSF at 8:07pm after we took him off life support.
Rash on various parts of body starting with neck and forearm.  Not at site of injection.  Using Benadryl po and steroid cream.
Janssen COVID-19 Vaccine EUA Symptoms started with a minor headache approximately 10 hours after receiving vaccine; I had dismissed it as a result of too much time in front of a computer screen. The next morning I was nauseous, head was hurting,  and then started to develop chills at about 10am.
Chills; Chest pressure was noticeable when he was about to go to sleep; He had a hard time sleeping because of it.; Lightheadedness; A sharp shooting chest pain afterwards; A sore arm/Soreness in left arm; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 16:30 (age at vaccination 38-year-old) (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. The patient past Medical history included asthma (has been diagnosed for a couple of months but has had this his whole life),gastroesophageal reflux disease (Additional Information for Other Conditions: caller has been diagnosed for a couple of months but has had this his whole life , death of relative). Concomitant medication included pantoprazole taken for gastroesophageal reflux disease and Albuterol [SALBUTAMOL] for asthma. Patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 04May2021, the patient experienced lightheadedness there was an initial rush right when he got the shot. It subsided and he stayed for 45 minutes and then he felt fine. Then, it came back when he got ready for bed. He is still having it today and he also had chest pain and thought it was from the soreness from his arm, but it is not going away. On an unspecified date the chest pressure was noticeable when he was about to go to sleep. There are still traces of the chest pain. The chest pain was yesterday but was not severe until the evening. It has gotten better and Last night it was was rough. The left arm, soreness is still there like someone hit him with a baseball bat. He wants to know what is normal for side effects of the vaccine, because he knows that like fever and stuff are. He did research online and was not finding much on this. He knew his arm would hurt. The patient is treated for the pain on the arm he took 200 mg Ibuprofen before bed. He has taken a multivitamin this morning. The event outcome was not recovered for a sore arm/Soreness in left arm, chest pain and lightheadedness and for rest of the event was Unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pain; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds reported  No treatment information provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Per patient statement on the day of vaccination, she had a sore right arm localized to shot area with shoulder pain and gradually had gotten to the point were it is hard to move arm around and painful at the site. No visual swelling. Upon movements feels like contractions to the muscles. No warmth to right arm. Denies fever/chills. No erythema. Denies nausea or vomiting. Denies headaches or dizziness. She states she does not plan to see PCP/Urgent Care or ER.
11281 Pt c/o itching & raspy throat after observation time lapsed. Pt no s/s of distress kin warm & dry. Lungs sounds clear in all fields. No resp distress noted V/S 122/84- 74-20-97% RA. Benadryl 50mg Po given @  1131 pt swallow pills w/o difficulty noted. EMS called 1130 arrived @ 1136 v/s & assessment completed Pt signed waiver refusing to  taken to ER near by.  Pt requested to call significant others for ride home while we continue monitoring. 1138 No changes in conditions  V/s taken 144/80-67-20 99% RA.  Pt stated Benadryl given was helping voice not as raspy. Pt picked up by Significant ohers. No s/s distress noted
This spontaneous report was received from a pharmacist regarding a 82-year-old female patient. There were no concomitant medications, pertinent medical history and known drug reactions or allergies reported. On 10-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly, lot # R012632, expiration date 15-JAN-2020 (strength and dose were not reported), for prophylaxis. On the same date, the patient experienced area around injection site (reported as "4 inches below and to the right of injection site") being painful, red and warm. The patient sought medical attention and returned to the pharmacy on 12-OCT-2018. No lab diagnostics or studies were performed. It was reported that treatment was given for the events and the patient took an unspecified dose of TYLENOL or MOTRIN. The outcome of the events was unknown. Causality assessment was not provided.
Patient was given a vial that had been drawn up previous night (5:30-6:00PM) at approx. 11:00 AM the following day.
This literature marketed retrospective pregnancy report as received from a physician refers to a female patient of unknown age. Information was received from a published article. A case of congenital rubella syndrome in a child born to a vaccinated woman who had not traveled internationally. In 2008, a full-term boy was born with microcephaly and a petechial rash. The infant's mother reported no rash illness, travel history, or known contact with ill persons during the first 4 months of pregnancy. She lived with her 2 other children and the case-patient's father, who had not traveled internationally during the mother's pregnancy. In 2002, the case-patient's mother had an equivocal rubella virus IgG titer of 5 and in 2003 received measles with M-M-R II vaccine. Vaccination status of the father was unknown. Maternal rubella virus IgG titer at 4 months' gestation was >400 IU/mL. The infant was delivered by urgent cesarean section because of cardiac decelerations during labor. Apgar scores at 1 and 5 minutes were 9 (of 10 total). At birth, the child weighed 2.7 kg (10th percentile), and he was 48.25 cm (15th percentile) in length and had a head circumference of 31.75 cm (<3rd percentile). He had a petechial rash on the face, back, and upper extremities and a systolic heart murmur. No jaundice or hepatosplenomegaly was noted. On 2003 the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced lack of immunity after vaccination. The clinical features and laboratory results for this case were most consistent with CRS, although initial testing was delayed until the infant was 6.5 months of age. Clinical findings for the case-patient (microcephaly, developmental delay, congenital heart disease) were compatible with CRS and met 3 of the Council of State and Territorial Epidemiologists' laboratory criteria for a confirmed case of CRS. CRS occurs rarely in children of women with a history of vaccination or documented immunity by rubella virus titer. When CRS does occur, it is frequently a result of asymptomatic rubella reinfection in the mother (5,6). In this case-patient, CRS was likely the result of 2 rare events: his mother's lack of immunity after vaccination and her exposure to rubella in a highly immune population. When the infant was 7.5 months of age, RT-PCR was positive for 1 of 2 specimens. However, when the infant was 10 and 12 months of age, RT-PCR was negative, as were culture results when the infant was 7.5 and 10 months of age. These findings are consistent with the diagnosis of CRS because for around 50% of children with CRS, culture results are negative by 3 months of age. The action taken with the therapy with M-M-R II was unknown. The outcome of the events was unknown. This case is linked to case number 1409USA007576 via mother baby link. Additional information has been requested.
Patient said the morning after the vaccine he started getting "lightnine bolts" in his vision that has persisted into Saturday and as of Saturday evening he had eye pain in his right eye.
Patient received vaccine from community based pharmacy on 11/15/19; 2 days later (11/17/19), developed confluent, highly erythematous popular with few vesicles rash on left posterior upper back, shoulder, anterior armpit, chest following C8-T1 dermatome distribution and few popular lesions on left medial forearm (C8 distribution); not painful but itchy but rash character highly consistent with shingles lesions. No systemic symptom except mild fatigue day prior to onset of rash. Treated empirically with Valacyclovir.
Janssen COVID-19 Vaccine EUA 5 minutes after receiving the shot, I was sitting in my car waiting for the 15 minute monitoring period, and I passed out.  Help responded and I came out of it, and proceeded to vomit 4-5 times.  Felt weak, dizzy, nauseous.  My mom came to drive me home.  Slept the rest of the morning and had some feeling of tightness in my chest in the late afternoon and evening.  Thursday morning when I woke up, my arm was sore but I felt mostly better (still a bit of tightness in the chest).  Did not seek medical attention at this time - just monitoring symptoms as of Thursday, 4/8/21.
No additional AE reported.; An improperly stored dose of VAQTA was administered to the patient on 26MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-MAY-2022, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # U033212 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported as 28-OCT-2022 and establish as 07-NOV-2022) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 54.4° Fahrenheit (F) for 11 hours respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 211AZ1A, 211A21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-DEC-2021, the patient had symptoms of chills and fatigue while she was at work and thought the chills were due to low temperatures at work but then she left work early due to fatigue and tested positive with a rapid test at home. On 30-DEC-2021, the patient reports symptoms of cough, fatigue and chills and took another home test and tested positive again (coded as suspected clinical vaccination failure and suspected covid-19 infection). The patient had not taken a polymerase chain reaction test nor have seen a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211266275-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Vaccines given 1030A. When he woke from nap at 3P mom felt like "he couldn't walk." He did stand and he did walk a little. she felt his limbs were weak. He was given Motrin. Also called 1/23 and felt his limbs were weak by 10pm pt was fine (not seen by MD).
Date and time of vaccination: (list both if they received both shots):   1-12-2021  @ approx 2pm    Moderna LOT # 012L20A 2-9-2021 @ approx 2pm     Moderna LOT # 029K20A
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-JUN-2018, the patient was vaccinated with first dose in the HPV vaccination series with GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported), on 08-OCT-2018, the patient was vaccinated with second dose of HPV vaccination series with GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported) and on 02-JAN-2019, the patient was in the pharmacy for her third dose of GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported) (Inappropriate schedule of product administration). It was reported that this was an altered dosing schedule. No adverse effects were reported.
Persistent headache not improved with over the counter treatment of ibuprofen and acetaminophen. As well as numbness and tingling of both arms. Symptoms started the day after vaccination and have not subsided.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. No concurrent conditions or medical history were provided. On 10-SEP-2014, the patient was inadvertently vaccinated with a dose of PROQUAD (merck), injection administered subcutaneously (dose, indication, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
C/O nausea and vomited x1.  Noted to be sweating excessively.  Medics alerted @ 4:34pm.  Vital signs via response team:  90/45 sitting, 91/66 standing, pulse 62, Pulse ox 100% on room air.  Alert and responsive.  Client verbalized that he was feeling better.  Client released in the care of his whom was on site.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Patient had a "cool" sensation in her throat-Severe, Systemic: Vomiting-Severe, Additional Details: Patient felt as if she may vomit.  She did not vomit while in the store.  I called paramedics after Benadryl was given.  I have not had any other contact with the patient or the paramedics since the incident.
Early in May of 2021 I stared having pain in my right hip. I have tried muscle relaxer, physical therapy, prednisone. Nothing has helped 100% these things give little relief then the pain come back.
(5/11/1983)Client received the 1st COVID vaccine Pfizer lot #EW0162 and expiration date at  04-16-21 4:45 pm in right arm. EMT reported that the client walked up to her and reported he was feeling anxious and has history of panic attacks. EMT, PHN and RN responded. RN noted that the client walked up to the EMT. Per EMT, client reported he was feeling anxious and has history of Anxiety attacks. In small observation area, client states "I was fine until I stopped distracting myself with my phone". Furthermore, he reported " I always get nervous that I am going to have an allergic reaction". Client reports history of panic attacks. Client reports he takes Pepcid, Denies any other medications. Denies allergies. Client was placed in semi-fowler's position. Vital signs at 11:04 am RR 18, BP 134/98, HR 102. Client Alert and oriented to person, place, date. Client advised of additional observation time added 30 minutes. Vital signs at 11:16 am BP 122/82 HR 96. Vitals Signs at 11:26 am BP 124/84 HR 88.  Client given information on v-safe and advised to sign up by PHN. Client given ER precautions and advised to f/u with PCP. Symptom resolved at 11:27 am. Client walked out of facility with steady gate. Client to be driven by wife. No further actions at this time.
Pt complaining immediately of feeling light-headed and feeling very hot. She said that she "blacked out" for a few seconds. Pt appeared very pale. Pt sat on chair for approximately 15 min. Said she felt better before leaving Rx.
Change in menstrual cycle. Light spotting for over 2 weeks at day 22 of my usually regular 30-32 day cycle. Still no full period on day 33. Not pregnant.
Rash developed on left arm about 3 inches away from the injection site which i noticed about 23 hours after the shot.   Rash was about the size of a quarter.  By night time it had tripled it's size.  By night on the 6th, it was about 3 inches down and about 5 inches across.  It is tender to the touch and raised.  It does not feel warm.  During the first 36hours after the shot I felt achy (no fever) and sore.  Slightly nauseous.
Extreme fatigue. Brain fog. Muscle aches. Nausea. Mild fever
Shortly after receiving the first shot, I started getting numbness and tingling in my left hand. I received the shot in my left arm. The numbness / tingling still continues today.
Pt. received 3 shots on Friday 6-19-15. DAPTACEL, IPOL, PROQUAD. Mom noticed pt leg was swollen to a softball size knot in her left leg which was hot to touch. Mom called me on 6-22-15 which I made her an appointment to have Dr. look at it.
He seems confused than normal; slept all day after getting home; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home). At the time of the report, CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
chest pain; chest pain, near his arms like the upper the pectoral muscle like and it not just the site where he get the vaccine; bad pain in the both sides; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced chest pain, near his arms like the upper the pectoral muscle like and it not just the site where he get the vaccine, bad pain in the both sides. The outcome of event was unknown.  Information on Lot/Batch number has been requested.