chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 2 December 2013 the subject received a dose of FLUARIX (unknown details). On 2 December 2013, less than one month after vaccination with FLUARIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
extreme anxiety; chest tightness and pain; chest tightness and pain; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an un-specified route of administration, administered in Arm Left on 06May2021 as dose 2, single for covid-19 immunisation (at the age of 24 years). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter reporting on behalf of her son. He received his second dose of the Pfizer Covid vaccine on 06May2021 and has since experienced extreme anxiety, chest tightness and pain. Caller wants to know if this has bene reported before. His MD diagnosed him with anxiety. Reporter stated that her son received his second dose last Thursday, and he has tightness in his chest and a little bit of pain in his chest every so often, and he is anxious for over a week, and it is still going on. Caller states he has been checked by a physician and she thinks it is anxiety. Caller states she is calling to see if anyone has reported this or if it is common. Caller states it is very concerning. Reporter stated that her son received his second dose of the Covid 19 vaccine last Thursday, 06May2021 and he's experienced tightness in his chest, a little bit of pain, and anxiety over it. He went to the doctor and the doctor thought he was having anxiety and that was what's causing it. He's 24 years old. She's filed a safety report already. Report number 4M8CBO0J. She just wants to speak to someone about her son's symptoms. The outcome of the event anxiety was not recovered, outcome of the events chest tightness and pain was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, fever, muscle aches, sore arm, headache, dehydration, tingling in fingers. This lasted 24 hours.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
PATIENT RECEIVED PFIZER BIVALENT BOOSTER ON 12/08/2022. PATIENT HAD ALSO RECEIVED A BIVALENT PFIZER BOOSTER ON 09/23/2022.
After the first dose of Moderna on 1/2/21, i experienced extreme fatigue and nauseousness, migraine, and tenderness in my left arm.  Almost immediately after receiving the second does of Moderna on 1/30/21, i experienced extreme dizziness, headache, nauseousness, chills and whole body shakes.
About 1 hr p/getting inject, pt became nauseated; by evening site around inject swollen & red; Seen by MD told to go home & lay down, put ice pack on arm & not eat till nausea better; a/inject, was on antibiotic for sinus infect;
patient tested positive for COVID after receiving the first dose; patient tested positive for COVID after receiving the first dose; This is a spontaneous report received from a contactable pharmacist (patient). A patient of unspecified age and gender received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient tested positive for COVID after receiving the first dose. The patient underwent COVID test and showed positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Feel dizziness; 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 DIZZINESS (Feel dizziness) 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 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feel dizziness). At the time of the report, DIZZINESS (Feel dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  Treatment medication information not provided
1 of 3 pts who exp an inject site react which included 3-4" of induration & erythema w/in 48 hrs p/vax; treated w/APAP & warm compresses; pt recovered;
groggy, diaphoretic, urinary incontinence, feeling hot Narrative: After receiving covid vaccine, pt found unresponsive with head rolled back. 911 called. able to minimally rouse patient. VS taken. p 76, rr 22, bp 168/94, 98% spo2 on ra. pt placed on O2 21/nc, assisted to cart. remained groggy, diaphoretic, urinated on self. c/o "feeling hot". Ice packs placed at base of skull, armpits. denies any significant pmhx or hx of seizures. Pt taken to nearby hospital ED per ambulance. Wife reports he was monitored on gurney by the nurses station at hospital and they did an EKG, blood work, and urine sample. He was discharged from the hospital ED around 6pm that evening. Of note, Pt stated he urinated on himself because he did not have time to use the bathroom before his vaccine appt; pt has a history of BPH.
Menactra that reached 33.5 degree Celsius was administered [Incorrect product storage]  Case Description: Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.   This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660. (Same reporter).   This case involves a 11 years old patient (gender not reported) who was vaccinated with 0.5 ml first dose of vaccine MENINGOCOCCAL VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines reached at 33.5 degree Celsius that day.  Medical history: not reported.   Concomitant medications included patient was vaccinated with a dose of HPV VACCINE.   It was an actual medication error case due to incorrect product storage.   It was unknown whether the patient experienced any adverse event post vaccination.   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.   List of documents held by sender: none.
pt recv vax; began to have sharp pains, worse at site; lateral movements cause most pain; worst pain in shoulder joints; shooting pains at site;
4 days after vaccine- pt developed painful reactive lymphadenopathy in left axilla ALSO developed acute left supraclavicular tender lymphadenopathy (seems atypical)
Light headed and dizzy , headache, body aches, chills, pain radiating from left shoulder to bottom of left leg.  Severe muscle  aches.  Fatigue, sleepy and foggy.
This spontaneous report was received from a nurse practitioner via company representative and refers to a 31 year old male patient. The patient's mother has history of fainting when getting shots. On 19-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose number unknown), subcutaneous (vaccines required for college), M-M-R II (dose number unknown) subcutaneously and Tdap intramuscularly. On 19-AUG-2014, after therapy with VARIVAX (Merck) and Tdap the patient became nauseous. Then he was given M-M-R II and the patient fainted. He had fixed pupils and was rigid with straight arms and hands curved back. He was awake and snoring and might have had a seizure. The patient was made to wait an hour and half before leaving, his parents were called to get him as he was not permitted to drive. There was no treatment rendered for the events. The outcome of the events were unknown. The causality was unknown. The patient sought medical attention. Additional information has been requested.
10 days later injection site still has soreness & pain with movement. Patient complained occassionally has mild spasm with pain even when not moving her arm. She has been taking Tylenol for pain off & on.
Redness at site started evening of same day administration migrated to the whole upper arm, pain and warmth.  persistent pain since November admin date in injection site upper left arm feels her ROM is affected
Pt called to report a reaction from the flu shot. She has some swelling in her arm about 2"x2" and her arm feels "heavy and sore". She sounded very agitated and was concerned about dealing with "student pharmacists". Recommended her  Benadryl and ibuprofen and to watch the site. . Explained that there are always possibilities of experiencing a localized reaction with any vaccine. She was worried about nerve damage. She is not experiencing any other symptoms and will keep an eye on it.
I had no severe reactions to the first two Pfizer vaccinations other than a bit of sore arm and a bit of headache. ---  Friday 9/24 - beginning of Saturday 9/25: OK, except for at bit of sore arm.  Evening of Saturday 9/25 and all night: Joint pain starting in right foot and moving upwards, to all joints, headache, fever (38.1), sore throat. Sunday 9/26 all day: Very,  very sick, continuous severe headache, nauseous, dizzy while lying down, fever (37.8), severe stomachache, completely unable to move or get up, unable to eat anything.  Sunday evening late: Husband helped me to toilet to urinate, and when he got me back to bed, I fainted in bed, he shook me and caland I came to, then I threw up for quite a while. Cont 14 days earlier I had gotten the yearly  flu shot, the one without egg. I regularly get allergy shots. I had tried a cholesterol medicine. Repatha injection every 14 days, two injections in August 2021, but had stopped in August 2021 it due to side effects.   1st Pfizer vaccine was 01/30/21 Lot # EL9264 2nd Pfizer vaccine was 02/24/21 Lot # EL 9267
Patient was given Flu shot by house supervisor, around 130 am while on -shift. At 0312 patient called reporting redness to site, swelling, itching at injection site and numbness to tip of tongue. Contacted Dr-ED provider, patient escorted to ED for evaluation. ZANTAC and Prednisone given.
Hot and cold flashes; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Hot and cold flashes) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FLUSHING (Hot and cold flashes). At the time of the report, FLUSHING (Hot and cold flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
extremely ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Vaccination, reaction(s): "extremely ill". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "extremely ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300073036 Same patient/event, different dose number;
This spontaneous prospective pregnancy report was received from a nurse practitioner concerning a female patient of unknown age. The patients pertinent medical history, drug reactions/allergies were not provided. On 18-SEP-2013 (start date also reported as 18-SEP-2013 or 19-SEP-2013), the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date were not provided, dose and route not reported). No concomitant medications were reported. It was reported that the patient conceived around 08-OCT-2013 three weeks later. The last menstrual period was approximately on 24-SEP-2013 and estimated delivery date would be approximately on 01-JUL-2014. No adverse effects were reported. The patient sought medical attention by consulting a health care professional. Additional information has been requested.
Eyes were nearly swollen shut; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) on unknown date for birth control. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 06:00 the patient experienced eyes were nearly swollen shut .The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event eyes were nearly swollen shut was not recovered.  No follow-up attempts are needed. No further information is expected.
Grand mal sz lasting 30 mins approx on 08JUN92; paramedics called, Valium administered to stop sz; hospitalization required; no known cause of sz in completely healthy infant (5 mo old); sent home of PB & still requires medication;
Yesterday I got the Johnson and Johnson vaccine. I was the last appointment, so they observed me for 5 minutes, and I left. After riding in the car for a few minutes, I noticed that I was having a hard time breathing and my throat felt like it was starting to swell. By that time, the clinic was closed, so I went to the emergency room just in case and sat in my car since they didn't allow people to sit in the waiting room because if covid.  It started becoming increasingly difficult to breathe, and I was feeling more and more swelling of my throat and tongue. I was having a lot of dizziness, nausea, facial flushing, palpitations, and some mild confusion. I then started getting numbness in the bottom half of my face. Over time, the numbness spread, mostly staying on the left side of my body (face, scalp, lower arms and legs, left side on tongue and inside of mouth). I also started getting a prickling burning pain sensation for brief periods of time where I had numbness. I had decided that if my breathing worsened at all, I would go to the er even though I can't afford it.   After about an hour and a half, my breathing started to feel less constricted and like there was less resistance. The swelling in my throat was mostly in the upper throat where I had difficulty swallowing but not as much difficulty breathing. The numbness continued to get worse and was sometimes disappearing and reappearing in the same spot.  At 9:30 pm we went to go get some benadryl. I continued feeling less and less swelling and having an easier time breathing. At that point, I went home. Once I was home, my breathing continued to improve and the numbness started to dissipate.  In the middle of the night, I started itching and getting widespread hives and getting a sharp burning pricking pain that would last a few seconds in different areas. The numbness also started coming back mostly in my face. I continued to have difficulty swallowing.  I am feeling much better today. I still feel some slight swelling in my throat when I swallow, but my breathing is fine. I'm still itchy and occasionally breaking out in hives. Im having mild lower facial numbness. I'm also starting to get the normal side effects of fever, headache, arm soreness, and body aches. I'm taking benadryl every 4 hours.
Flushing/sweating, dizziness. BPs 92/51 (pulse 60), 101/67 (pulse 74). O2 sats 100%.
Gave PREVNAR 10/28/15 approximately 5 days later 7 cm x 9 cm erythema and induration about injection site.
AFTER THE VACCINE IT WAS DESCRIBED AS AN ALLERGIC REACTION. ONSITE EMS WAS REQUESTED WITH PHYSICIAN, SHE WAS TREATED AND TRANSPORTED TO THE LOCAL HOSPITAL
Approximately 20 minutes after vaccine was administered, patient developed a red spotted rash to neck and chest area and stated her tongue felt thick and felt very warm.  Patient was given 0.5mg Epi and 50 mg Benadryl IM @ 3:53 p.m. and 3:55 p.m.  EMS came, client declined transport.  Client taken to ER by her husband.
Patient did NOT have adverse/allergic reaction to immunization given. The CDC recommends the following "This vaccine should not be administered to children aged <4 years or >7 years; however, if DTaP-IPV (Kinrix) is inadvertently administered for an earlier dose of the DTaP and/or IPV series, the dose should be counted as valid and does not need to be repeated provided minimum interval requirements have been met".  Parent/Guardian contacted about immunization error as well as CDC recommendations.
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/31/2021). Patient was admitted to the hospital on 7/5/21 for cough, poor appetite and dizziness for at least 3 weeks and tested positive SARS-CoV-2. On admission patient was febrile to 100.3, O2 SAT 95% on RA but desaturated to 89-90% with ambulation. He did not receive any COVID specific therapies and was discharged in stable condition on 7/7/21.
pt recv vax & pt devel red spots, worsening on 3/21/98 which were described as a total of nine red, raised papules located on arms, trunk & scalp;pt also exp rt eye erythema & drainage;seen by MD;
Chills, body aches, headache, low fever, fatigue for about 24 hours. Only treatment was fluids and rest.
I have no had a period since the vaccine - I am not pregnant - haven taken a pregnancy test.. I have never missed a period in the past
01/06/22 presents to ED for "abdominal pain". PMHx of "asthma, diverticulitis, OSA, gastric bypass"
Adverse event: myalgia (muscle aches) shivering. Treatment: ibuprofen Time course: 36 hours.
Warmth, redness and itching around inj site and down to elbow starting 3/14 to present. Applied cold packs, was seen by PCP 3/16 who is treating as an infection and put on antibiotics. I believe looks like allergy reaction further suggested antihistamine and ice.
swollen lymph node - painful - bewteen size of golf ball and tennis ball. Took ~ 1 week to resolve. In left arm.
On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced before in my life. Every time I move my arms, fingers, or apply any amount of pressure on any part of my arms, I will get a surge of pain raining down on my arms and only my arms from the shoulder down. At the same time, I also felt a surge of energy/adrenaline flowing throughout my legs, from the pelvis down, urging me to move around. I tried to force myself to sleep (without medication, just forcefully closing my eyes and trying to sleep) to no avail, so I got up and walked around my room and did some leg squats exercises without moving my arms too much from 11:10PM till 3:10AM, (I think getting my blood pumping throughout my body helped ease the pain a bit). The intensity of the pain on my arms decreased about half at around 3:10AM and I was finally able to fall asleep at around 3:30AM. I woke up once at around 7:45AM to go to the bathroom and drink some water. During this time, I think the intensity of the pain had dropped to 1/3 from when I first experienced this pain. I fell back asleep again and woke up at around 11:20AM. Most of the pain is gone by now, I only felt the lingering stings of the dreadful night from before. I continued to feel this phantom pain on both of my arms throughout the day and it wasn't until the day afterwards on the morning of 09May21 that relief was finally bestowed upon me.
Child told mom she was itchy and mom noticed hives from daughter's ears to her feet big and blotchy. Child complained of swelling in her hands. Child also complained of dizziness. Mom did not take child to doctor or gave child any medication for symptoms.
Patient 71 years old given a Tdap vaccine, which is only recommended through age 64 years.  Patient was called and notified of this.  Vaccination was administered on 2-21-08.  Patient was called 3-4-2008 and reported no adverse reactions.  There was not adverse event.
Initially fatigue and fever of 102 on the first day. Fever lasted for 2 days, After fever resolved individual noted raised bumps similar to fever blisters on the right groin. Report area is painful/burning which is intermittent in nature.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling bad and general body pain. On an unknown date, the outcome of the influenza-like symptoms, feeling bad and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling bad and general body pain to be related to SHINGRIX. Additional details were received as follows: The patient started experiencing flu like symptoms (felt lousy and body aches), the next day that lasted a couple of days. The patient did not inform her doctor of her symptoms, and stated, what was he gonna do. The patient had denied permission to contact their physician.
Beginning at 7 pm shaking, heart palpitations, profuse sweating, fatigue, leg cramps, sore/swollen throat.