chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine on 02/05/2021, on afternoon of 02/11/2021 came down with an itchy rash that is covering trunk, legs and parts of my neck and arms. None of the rash is near the injection site. Some of it is larger welts and some is small and unraised. I haven?t tried taking anything for it. I?m not allergic to anything that I know of and have never reacted to anything at all before- I don?t even get seasonal allergies. I guess that?s why they are thinking it could be vaccine related.
Short of breath, dizziness, dry throat, felt lump in throat and problems swallowing.  Given Kenalog 80 mg IM and Benadryl 50 mg IM. O2 started and transported to the ER per EMS.
queasiness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (queasiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (queasiness). At the time of the report, NAUSEA (queasiness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Information was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The medical assistant reported that an improperly stored dose of ROTATEQ 2 mL orally (lot # M038209, expiration date 23-APR-2018) was administered to a patient on 06-MAR-2017. No adverse effects reported. Information received was not because of a data logger. No previous temperature excursion. Temperature: between 0°C to 2°C; Time frame: 2 hours. No further information to report. Follow-up information was received from a medical assistant on 06-MAR-2017 concerning a patient of unknown age and gender. The medical assistant reported than an improperly stored dose of ROTATEQ (lot #M038209, expiration date 23-APR-2018) was administered since the previous excursion. Temperature: 1°C; Time frame: 1 hour. Previous temperature excursion: 0°C to 2°C for 2 hours. Clarification (16-MAR-2017): It was noted that the patient received only one dose of the improperly stored ROTATEQ on 06-MAR-2017. Additional information has been requested.
pt tested positive for COVID in SNF; to hosp for increasing O2 requirements; O2 sats in mid 80s on 10L via Venturi mask; PMH:  on immunosuppression for rental transplant and IV antibiotics for osteomyelitis of the hip; treated with dexamethasone, remdesivir, lasix, azithromycin, baracitinib; pt experienced cardiac arrest and required intubation, CPR and resuscitation initiated; achieved ROSC multiple times; given vasopressors; pt's condition declined; family chose to extubate and have comfort care; pt died in the hospital
Patient stated the below symptoms started about 6 hours after injection - hurts at the right side of where the vaccine was inserted - diarrhea - couldn't sleep on arm - headache - cramp on leg. Leg cramping and GI distress resolved next day.
1. 40 y/o  male with no past medical hx c/o lightheadedness and dizziness 8 mins after receiving the Johnson and Johnson vaccine. He reported that he came directly to site after a 12 hrs flight  and he last ate earlier this morning. He was assessed and monitored by NP, EMT, and paramedic. BP - 103/68, HR- 62, resp 14, O2 sat 95% on RA, had mild anxiety. He was given H2O and granola bar, allowed to lie down, instructed on relaxation measures. He was kept at site until he reported that he felt better, calm and had no complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs SEs to call 911 and go to the ED and that symptoms may occur up to 3 wks after receiving the vaccine. He verbalized understanding and willingness to comply. He noted that he will be returning to  on 6/8/2021. He left site in no acute distress, awake alert and oriented to person place time and situation, calm.
Soreness in site of injection; Headache; tiredness; mild chills; This is a spontaneous report from a contactable consumer (patient).    A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 50-years-old, as single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. tiredness on 10Feb2021 at 03:00 AM for 10-12 hours, and mild chills on 10Feb2021 at 03:00 AM for 6 hours. No treatments were given for the events.  The patient was not tested for covid prior vaccination nor post vaccination. The patient recovered from the event soreness in site of injection on 11Feb2021 (after 30 hours) and recovered from the events headache and tiredness and mild chills on 11Feb2021 (after 40 hours).  Follow-up attempts completed. No further information expected.
Patient received second dose of ROTATEQ on 11/4/14 at primary care MD office. Presented to Hospital on 11/8/14 with bloody stool and was transferred to another Hospital on 11/9/14. Intussusception was confirmed on sonogram and patient underwent air enema x 2.
hurt; chills; felt awful; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, chills and feels awful. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the chills and feels awful were unknown.   It was unknown if the reporter considered the pain, chills and feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and stated hurt like hell and spent a day or two to recoup, the patient also had chills and felt awful. The patient declined the 2nd and stated that hope he/she was the only one. The follow-up could not be possible as no contact details were available.
My son developed a severe headache, lethargy and could not get enough sleep.  His older brother had a severe reaction to the DTP vaccine as an infant where he screamed for hours with the first shot and the second could not be woken.  Doctor at the time contacted CDC and he was never given another vaccine of this type.
Caller was in the hospital when his second dose was scheduled and missed that dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (because of his diverticulitis an infection occurred causing a resection of his large intestine and an ileostomy) since an unknown date.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had pre-planned hospitalization to undergo surgery due to underlying historical medical condition of diverticulitis. Treatment included surgery of the large intestines, ileostomy and aspiration. This report refers to a case of incomplete course of vaccination for mRNA-1273,  with no associated AEs. Follow-up received on 14-APR-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI
Patient received 2nd dose of COVID VACCINE on day 14 .   VITALS : HR 87 RR 16 BP 154/86 O2 96%
Died; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) and HEART RATE IRREGULAR (irregular heartbeat) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Died) (seriousness criteria death and medically significant) and HEART RATE IRREGULAR (irregular heartbeat) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable.  Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Cause of death not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Cause of death not reported.; Reported Cause(s) of Death: Died
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was found deceased in his apartment. Chart shows a history of noncompliance to medical care and refusal to treatment of his CHF with an EF of 25-29%. He had not been seen in the clinic since 7/2020
Generalized delayed hypersensitivity reaction affecting legs, arms, abdomen, face. Maculopapular rash with confluent areas on right hip, left antecubital fossa
lump devel about 7-8hr in lt leg p/inj;broke out in rash resembling chickenpox as it's first breaking out;fever 1-2 days of 101-102;faintly colored papular rash everywhere;
Swelling of (L) lower extremity, mainly the foot, with mild redness 12.5 mg Benedryl POx 1 alternated heat and ice 6 mg Decadron IM x 1
Pfizer dose 2: 3/24/2021, Gym, Right Arm,11:30 AM                          3/25/2021 rash/hives and low-grade fever (took Benadryl)  Contacted a PA: She suggested Benadryl.  Also contacted a PA before getting the booster and they suggested switching up since I had a reaction to Pfizer.  Moderna booster: 11/27/2021 (Saturday), Pharmacy, Left Arm, 4:30 Symptoms: 11/28/2021 (Sunday) Sore arm, swollen arm pit, and achy (morning, all day)                                            (Sunday night) Hives/rash on my shoulders.                      11/29/201 (Monday) Sore arm and arm pit swollen more than Sunday (all day) hives/rash spread to neck, face, and down my sides. (took Bena 11/30/2021 (Tuesday) Arm pit still swollen but decreased a lot from Monday and still some rash/hives on the left side of my body (injection sight side).
Oct 2020 recieved quaddrivalent, left deltoid about 4 days after receiving the flu shot, any skin exposed to the sun turned an evenly red color within minutes.  It took about 40-60 minutes for the skin to return to normal.  We realized that when the skin was re-exposed to the sun, it still reacted, but not as red.  We then did 3-5 sessions in the sun daily for 15-30 minutes per session.  We did this for 2 weeks.  The skin eventual turned less red each time until a pink color and eventual it stopped after 2 weeks.   Oct2019 recieved quaddrivalent right arm, no reaction!   Oct 2018 recieved quaddrivalent, upper right arm The first time in Oct 2018, he received the flu vaccine and it was very similar, but we did not make the connection to the sun, as the episode lasted for 2 days and it was over.  It was more hives and redness, not an evenly red over exposed skin to the sun.  We talked with his doctor and we felt that since he has high histamine levels (he has skin dermographia) and he received the HPV vaccine at the same time as the flu vaccine, his body was hypersensitive and reacted.
No additional AE information provided; administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 18-MAR-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot number R013564 with expiration date on 13-MAY-2020 (strength , dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent  (lot number and expiration date not reported) used for reconstitution was properly stored.  The administered dose of the vaccine experienced a temperature excursion in the range between 15°F to 46°F (15.1°F) for 3 hours 6 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
injection site pain; arm was sore; This is a spontaneous report from a contactable consumer. A 55-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 14Apr2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included musculoskeletal shoulder issues. It was unknown whether the patient received other medications in two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021, the patient experienced some injection site pain and her arm was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcomes of the events injection site pain and arm was sore were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Caller reported patient received GARDASIL 9 doses on 10/8/2019 (at 11 years old), 10/15/2020 and on 11/6/2023.; No additional AEs or PQC; This spontaneous report was received from a medical assistant and refers to a patient of approximately 15-year-old of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-OCT-2019 (also reported as "at 11-year-old"), the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided). On 15-OCT-2020, the patient was vaccinated with the second dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided). On 06-NOV-2023, the patient was vaccinated with the third dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #1965044, expiration date: 07-JAN-2026 (strength, anatomical location, and route of administration were not provided) (inappropriate schedule of product administration). All given as prophylaxis. No adverse event was reported.
Narrative:  Patient experienced diarrhea, fever, and chills after receiving their 1st dose of the covid-19 vaccine. Symptoms resolved.
Rash developed 08/03/2003 over neck, shoulders and trunk.  Fever of 101F, low appetite, fussy.
PT WIFE STATED THAT PT FELT NAUSEA, WITH VOIMITING , LIGHTHEADEDESS, POSS SYNCOPE , PALE AND CLAMMY
pain at the injection site which radiates up to her collar bone,; extreme soreness; a knot that has developed at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site). At the time of the report, INJECTION SITE PAIN (pain at the injection site which radiates up to her collar bone,), PAIN (extreme soreness) and INJECTION SITE MASS (a knot that has developed at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Right arm with approximately 2 inch wide band of erythema and swelling completely around upper arm. blistering/ 'bubbling" approximately 1 inch in diameter at site of injection, no fever, complete ROM. Not complaining of pain. Patient's parents only noticed when pt was changing her shirt.
Mild sore arm; Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine) and MYALGIA (Mild sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025520-2A) for COVID-19 vaccination.     Concurrent medical conditions included Actinic keratosis (Chronic Actinic Ketosis).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine). On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Mild sore arm). At the time of the report, ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine) had resolved and MYALGIA (Mild sore arm) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-086721 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Actinic Keritosis event outcome was updated from unknown to recovered/resolved
Information has been received from a consumer concerning her 4 year old daughter who was vaccinated with varicella virus vaccine live at approximately 1 years old. Subsequently the pt experienced chickenpox. It was reported as a rash that was itchy and covered her back, but she had no fever or malaise. The outcome was not known.  The pt's sister (WAES # 0311USA01815) also experienced chickenpox after vaccination with varicella virus vaccine live. This reporter also reported that a first grade child (WAES # 0311USA01817) experienced chickenpox after vaccination with varicella virus vaccine live. Additional information is not expected.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Department of Health, notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from Department of Health are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
* fine vibration, like a low level electrical buzzing, fizzing, humming in legs and trunk just under the skin.  * always while lying down.
2 inch painful swelling/lump in right deltoid that was hot and bruise colored; also  swollen lymph node in arm pit that lasted 5-6 days; lump currently still present (4 weeks later), but smaller (size of a penny) and not hot, painful, or bruise-colored. Know.
vertigo; haven't been able to drive my car in 36 days; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Un-known), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced vertigo and haven't been able to drive my car in 36 days on an unspecified date. Patient asked are you getting calls from people who experience vertigo from the Pfizer BioNTech covid vaccine. I've already called in about this. I am a fairly healthy person. I've been sent for an MRI, MRA and vestibular testing. I found on (site name) 128 people who reporting experiencing vertigo after getting either the Pfizer or Moderna covid vaccine. I haven't been able to drive my car in 36 days. Caller confirmed receiving the Pfizer BioNTech covid vaccine. Response was no information available on the topic of vertigo within current information. Patient underwent lab test and procedures included MRI, MRA and vestibular testing showed unknown result. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
GARDASIL was the third injection. Almost immediately patient reported it was itching and it turned red. MD notified. Ice applied. No respiratory distress or further urticaria. When I interviewed patient's mother in the afternoon I enquired about possible latex allergy as a number of years ago I had a patient who mentioned that GARDASIL vial had latex in membrane. Patient had no further swelling, itching, and the redness was resolving.
The onset began approximately on 05/01/2021, I went to the podiatrist and she diagnosed me with bursitis. I was having heel pain. I never had this particular pain prior to the vaccination. I'm receiving physical therapy and  my adverse events are getting better.
Pt reported "feeling ill" and having a red, swollen, warm and hard area about 3-4 inches in diameter in left shoulder (site of injection) for 24-48 hours after injection. She also reports this is the first time she's had the High Dose vaccine. She did ice the area once a day.
102 degree Fever for two days  Aches -2 days Chills- 2 days Nausea/vomiting - 1 day Arm soreness at injection site- 3 days
7DEC93 pt recvd vax & 9DEC93 130PM pt started jerking, shaking & did not respond when mom called name lasted 1min; few minutes later happened again, also lasting 1min; 11DEC93 11AM another episode about the same as the first also lasting 1;