chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received shot at aprox. 3:10pm 5/10/21, she did bleed a little, band aide was applied . After stepping away to the designated observation area, patient returned to the vaccination area and took a seat stating she felt dizzy and light headed. Asked if that was normal, I said yes that's why we keep here. I began to ask other questions to determine if she has any additional complaints. She then suddenly appeared to lean her had back and began to fall out the chair. I was able to catch the patient before hitting the ground. My left hand had her left thigh, with my right hand supporting her neck and head until additional I was able to have additional assistance to get patient to lay on the ground to elevate her legs. When she initial "fainted" she was extremely stiff and her eyes were rolled back. Emergency services were immediately contacted. While myself and the Pharmacy Manager continued to make settle the patient she suddenly began to "awake" she was momentarily  disoriented, was quickly able to acknowledge her name, location, year and president. At 3:14 pm patients BP: 157/94 HR 103.
Hypertension, dizziness, nervousness. Treated at Emergency Room, discharged around 2 am, treated around midnight.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.
gave an expired Menactra/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a female patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX).  On 14-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA (expiry date: 06-Oct-2019).  It was of actual medication error due to expired vaccine used..  It was unknown whether adverse event was noticed or not..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .
sore arm; swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands). At the time of the report, PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Joint pain. Subsided they reoccurred with much more intensity. Could barely walk my right knee hut so badly. Other joints can and went but knee just intensified. Today both my eyes are vpred , swollen and stinging
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED ( patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient age reported as 48 years.  No concomitant medications were provided by the reporter.      No treatment medications were provided by the reporter.
Standard side effects like chills and fatigue during first 36 hours of vaccination.  I started having muscle weakness On day 5 after vaccination. First, I could not wake up in the morning. I had pain and heavy feeling in my legs. Next day I started having pain in my chest in addition to leg sensations. Next day on 9/21 I was walking home and It was hard to move my upper sides of legs, it is like you want it , but legs felt so heavy. On 9/22 I started having similar issues with my arms. They became kind of weak and heavy. It was hard to do work with my arms and hands. I became clumpy, everything was falling from my hands. Now I have weakness pain and heaviness in both legs and arms. Sometimes it more sometimes it less severe. Plus it accompanied with headache.. Doctor suggested neurological issues like neuropathy due to Covid vaccination and relapse of Chronic Fatigue Syndrome which I was able to control for last 1.5 years.
Information has been received from a physician concerning a 7 year old white male who on 02/13/1996 was vaccinated with a second dose of varicella virus vaccine live SC in the left arm. Concomitant therapy included diphtheria toxoid/pertussis vaccine/tetanus toxoid. On 02/09/2002, the pt developed approximately 15-20 lesions for 1 week. No additional info is expected.
About 10 hours after my 2nd dose of the COVID19 vaccine I experienced the symptoms of fever, aches, and armpit lymph node pain on the side of the injection.  The fever and aches went away after 24 hours, but severe lymph node pain remained for 2 weeks.  The pain and full feeling in my left armpit subsided slightly but never completely went away.  Now, over 3 months after the vaccine, the pain is a bit better, but the feeling of fullness and discomfort in my left armpit remains.
PARALYSIS; INCONTINENCE; COULD NOT SIT UP; RIGHT LEG SWELLING; EXTREME LEG PAIN (RIGHT); EXTREME WEAKNESS/OVERWHELMING WEAKNESS; LEG'S COLLAPSE; This spontaneous report received from a consumer concerned a 65 year old male 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 (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on end APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021 or 25-MAY-2021 the patient's legs collapsed under him. He spent 4 days on the floor prior to being able to get medical assistance. Reporter had to call fire department to get him evacuated and was transported to the hospital via ambulance. On an unspecified date, the patient experienced paralysis, incontinence, could not sit up, right leg swelling, extreme leg pain (right), and extreme weakness/overwhelming weakness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralysis, extreme weakness/overwhelming weakness, incontinence, extreme leg pain (right), could not sit up, right leg swelling and leg's collapse was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210727800- covid-19 vaccine ad26.cov2.s-Paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient fainted within 15 seconds of receiving vaccine. Patient came too approximately 15 seconds  after passing out. Patient was nauseated and dizzy for another 10 to 15 minutes. Pharmacy called local emergency squad to evaluate patient. Patient refused to be transported to local hospital. pharmacy made your patient had someone take her home. Contacted patient the next day and patient said she was feeling better. Patient believed it was "needle anxiety" and does not believe it was caused by the vaccine itself.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing), notes: Other medical history: Diabetes II (For 25 years). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 18May2022 to 22May2022 for the treatment of COVID-19. after 5 days from the date of last Paxlovid pills Virus reappeared.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
arm has turned bright red around the injection sight. The injection sight is warm to the touch and hard when you touch it. It is a dark red circle closer to the injection sight and looks lighter as you go out. Almost looks like a bullseye.
stomach cramps, n/v x 2 days;joint pain in all joints & stiffness x 2 wk;
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2011, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 03-DEC-2016, the patient was treated by a registered nurse/RN at a health care facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 11Oct2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 20Oct2021 at 13:15, the patient experienced racing heart, vertigo-type symptoms, brain fog, floating sensation in limbs, pressure in temples and onset anxiety. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events racing heart, vertigo-type symptoms, brain fog, floating sensation in limbs, pressure in temples and onset anxiety were not resolved at the time of this report.
In June without medication and I had the first fainting 12 days after receiving the vaccine. On August 30 I had another fainting episode much worse than the first since I had two consecutive fainting spells, I ended up going to the emergency room. Twelve days earlier I stopped taking the sulfazalazine and prednisone. On September 19, I fainted 4 times in a row while I was being taken to the emergency trauma shock ward at the hospital. On September 24, while I was hospitalized, after doing 16 minutes of light exercises, I passed out again. I had three days on leflumide and prednisone. Now I continue to have dizziness.
1. Supra-ventricular tachycardia arrhythmia with cough. 3/06/21 11pm and lasted 15 days. Still somewhat present but much less the last 2 days. 2. 102.1 fever and severe myalgia and mod-severe nausea. 03/06/21 6pm to 03/09/21 6pm about 72 hours.
Rash near injection site, roughly 10 x 9 cm. Rash was red, raised, painful, itch.
19cm x 16cm redness and slight nontender swelling on the left anterior thigh w/ 9cm x 6cm more dark red discoloration in the center.
abdominal pain; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 12th May 2019, 1 days after receiving Shingrix, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. 1 to 2 days after vaccination with Shingrix, the patient experienced diffuse abdominal pain (musculoskeletal in nature). On day 6, the patient recovered 50 percent and on day 7, the patient recovered 75 percent for abdominal pain. The current status of pain was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.09. Concomitant products were not provided. On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
persistent screaming x 3 1/2-4 hrs same day of vax; pt was not taken to ER or clinic
day 1 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day. day 2 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day; took acetaminophen 650 mg q 4 hours x 4; defervesce day 3 post vaccination; swelling and erythema ay injection site  improved; mild general malaise but other symptoms resolved. .
Client reports - hives - itchiness (L) arm after PNEUMOVAX administration. Hives and itchiness immediately following lasting till AM. AM - arm 3-4 normal - redness - big ring around muscle - duration 1 week.
The adverse event didn't take place until May of 2023 but since it is an entirely new medical event for me I wanted to report it. In May I thought I experienced a heart attack but it turns out to be extreme and repeated panic attacks. I am using Zoloft and counseling to combat them somewhat successfully. I have no idea if this is related to the Covid vaccines but wanted to report it.
Fever > 100 while taking TYLENOL, ibuprofen. Nausea and refusing food and liquids. Lethargic. Unable to urinate > 15 hrs. Used thighs this time hoping last reaction was due to small arms.
pt recv vax & devel transverse myelitis, & was hosp, & is a quadriplegic;reporter was notified  of this event as part of litigation proceedings;
My son was fussy, as to be expected, immediately following his DTAP vaccine. His irritability lasted much longer than what is considered to be typical. He broke out in eczema the night of his vaccine. We noticed the eczema the morning after he was vaccinated. He also stopped babbling. He remained silent for about 4-5 weeks. He continued to be irritable during that time. I was not sure what was causing him to be silent. I thought it was curious it happened immediately after his vaccines. We treated his eczema with a detox of natural vitamin supplements and pro-biotics as directed by our new pediatrician. After treating him with this gentle baby detox for 2 weeks, he excreted out the heavy metals and began talking and babbling again.
A report has been received from a physician concerning a 31 year old, female subject, who had been receiving FLUMIST (Intranasal), 0.2 Millilitres, once/single administration. FLUMIST (Intranasal) started on 13-Sep-2013. The patient experienced exposure during pregnancy which started on 13-Sep-2013. FLUMIST (Intranasal) was discontinued on 13-Sep-2013. The outcome of the event of exposure during pregnancy is unknown. The report was considered to be non-serious.
Felt hot, had itching at injection site and then itching & hives back of neck.
Pts description "received the vaccine and a couple of days had a RA flair up. A few days after that, she started having parasthesia in her arms and legs and went to the ER. It has not stopped since receiving the vaccine"