chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had horrible dizziness and vertigo for five straight days. This was completely incapacitating and I could not even walk from my bedroom to the kitchen and the room was spinning for five straight days. It was the type of vertigo where I could not even shut my eyes because it felt as if the room was spinning even worse with my eyes shot and it was awful for five days. I am not a person who has a tendency to have any type of dizziness or vertigo and I don?t even know if I?ve had that more than maybe once in my life during a sickness and I cannot even remember when that would have been but this was very debilitating and very frightening. It was a complete neurological response and it actually frightened me to the point where I didn?t know if I would be able to drive or function normally for quite some time but I had around a week later it started to dissipate. Very scary stuff...
rash; redness; huge welp on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, erythema and welts. On an unknown date, the outcome of the rash, erythema and welts were recovered/resolved.   It was unknown if the reporter considered the rash, erythema and welts to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and experienced rash, redness and huge welp on the arm and all the symptoms lasted for several days. The patient would be receiving 2nd dose in January 2022. Follow-up would not be possible as no contact details available.
Information has been received from a RN concerning a 22 year old female with no past medical history and no known drug allergies who on 3/4/03 at 10 am was vaccinated in the right deltoid with the second dose of hep B vaccine (644848/1060M). The pt was vaccinated with the first dose of hep B vaccine recombinant on 1/17/03. There were no concomitant medications. There was no illness at the time of vaccination. On 3/4/03 at 10 am, immediately after the vaccination, the pt developed an immediate reaction a reddened arm. The reporter indicated that she then felt flushed and hot. No other symptoms or complaints were noted. The physician indicated that she does not believe that this is an allergic reaction. There were no events following prior vaccinations, and there were no relevant diagnostic tests or lab data reported. Follow up info received from a RN indicated that on 3/4/03 the pt recovered. No further info is expected.
Shot was given at 2:00pm on March 21st 2021.  At approx. 10:00am  on March 22,2021 patient started to experience involuntary leg twitching and severe pain in right leg.  Pain was located at the right leg sciatic nerve, as the pain traveled from the back of the heel up to the right buttock.  The twitching would occur every 1-2 mintues in 3-5 pulses up the leg.  Treatment was 2 Advil every 4 hours to ease the pain.  Also use of a roll on pain reliaver was applied( Icy Hot) in attept to ease the pain as well.  Patient had to stay in bed during the event due to pain.  At approx. 4:30am on March 23, 2021, pain and twiching stopped.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07/03/2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 5 days past the 30 day time in refrigerator.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 014F21A and 037C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Patient is allergic to Metformin). On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07/03/2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 5 days past the 30 day time in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07/03/2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 5 days past the 30 day time in refrigerator) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 07/03/2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 5 days past the 30 day time in refrigerator) to be not related. No concomitant medications were reported. Weight of the patient was given as 139 (No units provided). Race of patient was given as Hispanic. Patient had no Acute illnesses at the time of vaccination and up to one month before vaccination. The reporter reported that they had refrigerated some vials of Moderna Covid-19 vaccine more than 30 days. Reporter would like to know if the vaccine was still viable 30 days after the vaccine had been in the fridge. Reporter further stated that it was stored between 2 and 8 Celsius degrees. Dose was administered after 30 day use by date or after manufacture date of expiry. Lot number  046L21A. No of doses or vials 9 doses. Date the vial was initially stored in the refrigerator 07-Mar-2022. The vial had not undergone any temperature excursions. No treatment medications were reported. This case was linked to MOD-2022-546711 (Patient Link).
Throat swelling, blood shot eyes, neck/shoulder pain, tingling in arms/upper body, nausea, dizziness, sweating profusely, injection site pain (throbbing). Severe headache after reaction.
COVID-19; COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4014738-00 (AbbVie).  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Jul2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and intramuscular, administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1151650) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2021, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug Ineffective and suspected covid-19 with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
24 y/o male ADSM is referred by Research Nurse for inclusion in the Anthrax study.  SM reports increased erythema, swelling, and pain after each of his previous Anthrax vaccines.  The inflammatory response has decreased with each subsequent Anthrax vaccination.  Symptoms: Edema @ injection site 30-50mm, Edema @ injection site > 120 mm beyond elbow.
mildly enlarged axillary lymph nodes; Pain radiating to entire arm and hand; Very intense pain at injection site; Pain radiating to entire arm and hand; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and penicillin allergy. Concomitant medications were reported as not applicable. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248) via an unspecified route of administration in the left arm on 08Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 29Jan2021 at 02:00, approximately 12 hours after injection of 2nd dose, the patient experienced very intense pain at injection site and the pain radiated to entire arm and hand. The intense pain persists at injection site over 2 months post injection. The pain in left arm was causing limited motion range. Occasionally mostly during the night, very intense pain reoccurs at the time of report. On an unknown date in Feb2021, the patient experienced mildly enlarged axillary lymph nodes. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  On an unknown date in Feb2021 one week after 2nd dose, the patient underwent routing breast ultrasound screening and the result was mildly enlarged axillary lymph nodes. The clinical outcome of the events very intense pain at injection site, pain radiating to entire arm and hand, enlarged axillary lymph nodes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt received 1st dose of Moderna (019B21A) on 4/15/2021. Pt reports symptoms started the following day including headache, vomiting, fever (101.5F), body aches, fatigue, loss of appetite, and burning with urination. Symptoms lasted 4-5 days. Fever was controlled with ibuprofen but taken consistently over 4 days. On day 4 or 5 of symptoms, pt reports developing blisters in and around mouth and nose. Day 3 of symptoms, pt reports developing small red dots (not raised bumps) on arms and legs. All symptoms except headache resolved after day 5 of symptoms. Pt continues to experience mild headaches. Pt contacted primary care provider at clinic by phone, and per patient provider supected blisters were related to the fever and who did recommend receiving second dose. Unkonwn if PCP reported to VAERS. Pt denied experiencing symptoms the day of vaccination, denied experiencing rash, swelling or tingling in mouth or throat, difficulty breathing. Pt's husband had tested positive for Covid several months prior -- pt was tested at the time and resulted negative. Together we agreed the patient is okay to vaccinate per our standing orders.
Chills; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER2613) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Connective tissue disease" (unspecified if ongoing); "Aneurysm" (unspecified if ongoing), notes: I have an aneurysm on my heart; "AFib" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "lung cancer" (unspecified if ongoing), notes: I am a lung cancer survivor and also a have a decreased oxygen supply at night time. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; LORATADINE; LIPITOR; XARELTO; LEXAPRO taken for anxiety; LEVOTHYROXINE; TOPROL taken for atrial fibrillation. Vaccination history included: Bnt162b2 (Dose 01, Lot number; EN6205, Anatomical location; left arm), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "didn't have any symptoms at all". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Body ache". Additional information; Treatment: The patient stated "Tylenol." LOT for the Tylenol:, "The patient don't have that, the patient at work right now and my bottle of Tylenol at home. I can't take anything because I am on a blood thinner, so that's the only thing I can take is Tylenol. But the Tylenol did help but when the Tylenol start 'wearing' off I can really feel it because the chills start coming back really hard again. I was sick for 5 days, for last 2 days I had fever for 3 days and then the last 2 days after my fever broke I had profuse sweating, I mean bad like I couldn't sleep dry 'clothed', just like profuse sweating." The patient further stated, "I have had, when I got my first vaccine I didn't have any symptoms at all,  the second vaccine, I had chills and body ache for 24 hours and but then the booster put me in bed for 5 days." When probed if the patient had not any other vaccination 4 weeks prior to COVID 19 Vaccine, the patient stated, the first two were like in a hospital and the last one was done at withheld.  No follow-up attempts are possible. No further information is expected.   Follow-Up (20Jan2022): Follow-up attempts are completed. No further information is expected.
Arm pain and reduced range of motion, difficulty lifting even light items without pain, occasional shooting pains when using left arm. Discomfort was mentioned to primary care physician and chiropractor on several occasions.  Has not subsided in past 7 months.
I began feeling weak and my legs were like rubber on 11 Oct. On the 12 Oct I had trouble walking and fell down. On 13 Oct I couldn't walk so my husband took me to the ER. While there I lost the feeling in my feet and legs and couldn't move them. I was admitted and treated for Guillain Barre syndrome. I was transferred to a nursing facility for rehabilitation and am still there.
fever (103 as reported); chills; red arm; headache; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix and FLUZONE HD. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, chills, erythema of extremities and headache. On an unknown date, the outcome of the fever, chills, erythema of extremities and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills, erythema of extremities and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The patient experienced fever (body temperature 103 degree F), chills, red arm, headache and which lasted for 2 to 3 days. It was unknown if the reporter considered the fever, chills, erythema of extremities and headache to be related to Fluzone HD as well. The reporter consented to follow up.
local rt upper arm-swelling, red tender w/streaks; no lymphadenitis; fever;
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Concomitant medications were not reported.  Patient received the vaccine at 12:28 pm.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   The vaccine had been frozen with no known temperature excursion before being thawed for administration.  Date the vial was initially stored in the refrigerator was 24-Feb-2023.  The vial did not undergone any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712700 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Live follow up contains the administration time of suspect product.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712698:
Lymphadinopathy in Left armpit 4 days following vaccination. Pt reported to Medical 2 days after noticing adverse event. Pt given Ibuprofen, told to apply RICE  & told to return if symptoms do not resolve.
p/vax it was determined that pt was preg, in first trimester @ time of vax;no adverse exp had occurred @ that time;pt exp a spontaneous abortion;report considered medically important;
Large red warm wheal just distal to injection site. This appeared about 40 hrs post injection.
Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and subsided within 24 hours of vaccine.
I received the 2nd Shingrix vaccine on 12/24/22 and received the Pneumovax 23 2nd shot the week before on 12/17/22. I did fine with the Pnemonvax 23 so went for the second Shingrix. I felt sore and tired and thought that was it. On day 5, I started having some odd dizziness so went chose to rest and within a few hours, my eyes were so blurry and had dizziness to the point I could not stand up. This went on for several days through New Years. During this time, my heart was racing to the point of getting short of breath.  I wasn't sure if I was having a heart attack or stroke and felt it was time to see my PCP. When visiting my PCP, she called an ambulance and brought me to Emergency department. My blood pressure which is usually low was high, heart going up and down and feeling like I was going to lose consciousness.  They did an EKG and all looked OK as did my bloods. I was discharged and these symptoms continued and only today, 1/10/23 do I feel some improvement. Heart has settled down even though I am going to see a cardiologist this week to make sure all is good and the dizziness has improved. I am still left with a terrible headache that is constant. I did have an MRI with contrast which was clear. I have not driven, cancelled my life basically until this passes from a simple vaccine. This has been an absolutely awful experience prompting me to never take another vaccine again.
Extream all over muscle aches, headache, diarrhea, light-headedness
Two Enlarged lymph nodes above the collar bone and neck on the same side as the vaccine occurred (right). Noticed the first enlarged lymph node above my collar bone approx. 3 weeks after my first shot. 24 hours After my second shot that same node enlarged further and I noticed an additional enlarged lymph node approximately 1 inc above the first.
Pfizer Covid Vaccine; 26 y.o. female  who presents after feeling weak and dizzy after COVID vaccination. Patient received the vaccination at 1230 and is still symptomatic. There is no sign of anaphylaxis. Obtained orthostatics at bedside and she is not orthostatic. Patient appears very anxious. Will give patient juice and crackers as well as obtain a glucose. Gave the option to obtain labs however she declines at this time. Patient was given 216 oz bottles of water and a 12 oz bottle of grape juice and a muffin and also saltines.  Patient is now stable for discharge
I tested on the 13th because my 4 year old daughter was positive. The rapid test came back negative and I retested on the 16th with another rapid test and came back positive.
Patient developed dyspnea on exertion noted 7 days after his vaccine; Note that he had fully recovered from COVID infection  one month prior with cardio on bicycle without drop  off of performance metrics.   DOE was noticeable  on bike rides - almost had a syncopal  episode on a bike hill climb at post injection day 10; medrol dose pack started - symptoms resolved in one week. No sign of desaturation noted on pulse oximetry; patient elected NOT to pursue the second vaccination shot given the side effects.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 43 year old male consumer who experienced a stuffy nose.  At 43 years of age, the pt received a dose on 12/11/03. The pt's concurrent illness includes anxiety.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Lexapro (escitalopram) and Xanax (alprazolam).  On 12/11/03, the pt experienced a stuffy nose after receiving Flumist.  He was treated with Claritin.  As of 12/18/03, the stuffy nose had not resolved.  No additional information was available at the time of this report.
SWELLING/ INFLAMMATION BEYOND THE DELTOID, SPREAD INTO BICEP; PATIENT REPORTS SWELLING HAS REDUCED
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 29-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 29-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
PT CAME FOR A BOOSTER OF PFIZER SHOT. AFTERWARDS, PT STATED THAT SHE FELT FAINT AND FELL. PT WAS ESCORTED TO ROOM WHERE SHE WAS MONITORED FOR 30 MINUTES. NO PAST MEDICAL HISTORY. LAST ORAL INTAKE WAS THE NIGHT BEFORE. V/S ARE AS FOLLOWS: 1157: BP106/74 O2 100 HR 75 POST V/S: 1222: BP 107/71 O2: 99 HR 72.