chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next two evenings I came home from work exhausted, where I had to rest on the couch all evening.  On the morning of the 23rd I woke up with my right eye not being able to open all the way.  It was blinking frequently too.  Within 45 minutes my right side of my mouth was drawn like I was having a stroke.  An ambulance was called and my blood pressure was high.  At the hospital I was thought to possibly have Bell's palsy.  The next day the tinkling moved to the left.  My left forehead wouldn't wrinkle, my left eye wouldn't blink, and my mouth was drawn.  That puzzled the doctors because it moved to the other side.  They thought I might be experiencing Guillain Barre, but they didn't have a test to find out.  They recommended I start steroids and acyclovir.  Also, they suggested port placement and begin one plasma exchange.  Then the next day they would get me transferred to Hospital for a Blink Test.  At 12:15Am on Oct. 26 I was admitted to hospital.  They immediately said I didn't have GBS, but had bilateral Bell's palsy.  I was finally diagnosed with left side Bell's Palsy.  On Nov. 6 I started getting dizzy and nausea set in (vertigo).  I was treated with medi meclizine and ondansetron.  Then when that didn't take care of it I was put on transderm.  I am still experiencing problems.  I have a follow-up appointment on Dec. 3 at hospital.  I was asked to also put my influenza Oct. 7 notes here: Glaxo-Smith-Kline AFLUA460BA and CPT CODE: 90658.  12/02/09 DC summary for DOS 11/26/09-11/28/09 Final DX: L Bell's palsy, anxiety, essential HTA   Pt c/o R side sensory symptoms.  Pt has droopy face and partial numbness of L side. Bell's palsy confirmed. Pt had left facial twitching. GBS ruled out. tx: steroids, acyclovir.
Patient developed initial severe itchy rash that started on bilateral arms and webs of fingers three days after initial dose. Immediately preceding onset of rash he had eaten cereal and milk.  Within several minutes the rash had spread to his abdomen, chest, back and bilateral legs. He had swelling of the lips and tingling of lips. At this time he took three 25 mg Benadryl. He stated the lip swelling and tingling resolved however the left anterior leg to knee had a large, prurutic rash. This rash resolved with continuous Benadryl treatment for two days.   He presented to clinic on 1/26/2021 with similiar rash that occurred in the morning after drinking coffee. He had diffuse pruritic rash on abdomen, back, bilateral arms and legs. Some wheals on right lower leg. He stated he had tingling of lips but no swelling was observed. He had continuous movements of scratching his arms and legs and moving moving his arms and legs with  some contortion of facial expressions. He had taken three Benadryl prior to coming to clinic. He was given Pepcid 20 mg in office. Most of the rash resolved within 8 hours with minor bumps remaining on bilateral elbows which resolved after twelve hours.
Patient under the age of 18 received Flublok vaccine which is only indicated for patients over the 18. No adverse effects were reported during follow-up conversation with patient?s mom 12 days after vaccination.
Headache, Sedation, Myalgia, Fever, CHILLS AND PAIN Narrative:
No Adverse Event; inadvertent administration; This spontaneous report was received from an other health professional refers to a 7-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2023, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # W029724, expiration date: W029724, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis instead of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) (wrong product administered). No additional adverse event was reported (no adverse event).
This spontaneous report as received from a pharmacist via company representative refers to a 25 year old patient of unknown gender. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, frequency, lot#, expire date not reported). No concomitant medications reported. On an unknown date the patient experienced herpes zoster after receiving VARIVAX (Merck). The outcome of herpes zoster was unknown. This is one of the two report from the same reporter. (MARRS#1508USA005043). Additional information has been requested.
Narrative: A 51yo female with history of depression, had a telephone f/u contact from FT MD on August 19,2021. The MD's note included the patient reported receiving Pfizer Covid-19 vaccine, "had an allergic reaction, needed epi pen and called 911".-The Psychiatrist who contacted the patient reported a historical ADR of Pfizer Covid-19 vaccine induced Acute Respiratory Distress where the patient stated, had to call 911, received epi-pen and was taken to ER for treatment. No other detailed information provided.
Information has been received from a nurse concerning a "13 1/2 month old" patient (gender unknown) who on 10-MAR-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently"approximately six weeks after being vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process), the patient experienced a measles-like rash. The patient sought unspecified medical attention. As of the date of this report, the outcome of the patient was not known. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Feeling tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included DENOSUMAB for Osteoporosis.    On 07-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 FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Systemic: Anaphylaxis-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium; symptoms lasted 1 day
He had swelling on his right arm that spread below the elbow. It was getting better by the time he came to report this to me. I told him some cold compresses or BENADRYL. He said it was feeling better but wanted to know which vaccines caused the reaction.
site injection soreness and discomfort; body aches, rib cage pain Narrative:  Other Relevant History:
Pt came to clinic on 9-7-12 states her (L) upper arm is painful due to HD FLUZONE she received 09/06/12 (L) upper arm warm, red, tender, able to move. 2+ pulse, 3" x 5 1/2" in measurement. Pt sent to urgent care clinic due to feeling a little off & dizzy.
Itchy rash; After shower it worsened; some hives; itchy rash & hives around mouth, on stomach and back; with benedryl the reaction did not progress and is being given every 6 hrs.
A spontaneous report has been received from Pharmacist concerning a female patient. Patient's relevant history, concurrent diseases and concomitant drugs were not provided. She had been received FLUMIST Quadrivalent intranasal, started on an unknown date. During administration, patient moved and some of the vaccine sprayed up on the patient's forehead and eye. The outcome of the event of sprayed up some of the vaccine and the patient's forehead and eye was unknown. The reporter assessed the event of sprayed up some of the vaccine on the patient's forehead and eye to be non-serious.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EN6205) and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ58762) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Shot was received, in my left arm, on 3/17/21. The arm is aching to this day, 4/1/21
I developed tinnitus ~2 weeks after receiving my influenza and Covid19 (Moderna) vaccination.  Constant high-pitched ringing.
LOCAL REDNESS GREATER THAN PUNCTURE SITE WITH DISTAL STREAKING > 50 MM OBVIOUS INFECTION, SECONDARY CELLULITIS TX: SEPTRA 05, RIFAMPIN 300mg, RESOLVING
Extremely tired; Feverish; Flu-like symptoms; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Extremely tired) and PYREXIA (Feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Extremely tired) and PYREXIA (Feverish). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Feverish) had resolved and FATIGUE (Extremely tired) had not resolved.            No treatment and concomitant medication reported.   This case was linked to MOD-2021-037243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Therapy details were added.
This solicited report has been received from a nurse concerning a 46 year old female patient was enrolled in a market research program conducted by an agency.The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in July 2007 the patient was vaccinated with GARDASIL (dose, lot number and route of administration not provided) for prophylaxis. The patient reported that vaccination was painful but she continued with remaining doses on unknown dates in August 2007 and February 2008. The patient completed the series of vaccination. The outcome of painful experience was reported as recovered with sequelae on an unknown date in February 2008. The relationship between vaccination with GARDASIL and the event was unknown (also reported as not applicable). Additional information is not expected as the reporter did not give the consent to be contacted.
Headaches. Malaise. Diarrhea. Fatigue. Nausea.
This spontaneous report was received from a male patient of unknown age via company representative regarding himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported) for prophylaxis. On an unknown date in 2012, the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Pt was given Moderna as her 2nd dose in her primary series when Pfizer was her 1st dose
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE GENERALIZED TONIC CLONIC EPILEPSY TRANSIENT CEREBRAL ISCHEMIA
menstrual cramping (severe and 1 week before cycle); extremely heavy flow and pain; increased length of period (10 days - previously 4 days).  Worth noting, I had the Paragard IUD put in on March 15th. I was told this would effect the cramping but not the length and flow.
She became dizzy; Her ears are bothering her; Her head doesn't feel right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "She became dizzy"; EAR DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Her ears are bothering her"; HEAD DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Her head doesn't feel right".  Additional information: Patent received the 1st dose of the vaccine on 19Apr2021 but on Saturday she became dizzy and her ears are bothering her. Today (at the time of report) she was not as dizzy anymore but her head doesn't feel right.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom states that the evening of the day pt recv vax pt broke out in a rash all over body & lost appetite;rash was gone the next morning;
My Crohn's has been in remission for quite a while, but it's no longer in remission. I've been having Crohn's symptoms for the last two weeks. There is also a possibility of ovarian cancer which I still need to investigate further. I have no idea if these are in relation to the vaccine.
Ear hissing; This case was reported by a consumer via interactive digital media and described the occurrence of ear hissing in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ear hissing. On an unknown date, the outcome of the ear hissing was unknown.   It was unknown if the reporter considered the ear hissing to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced ear hissing after vaccination.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 01-MAR-2019, the patient received an improperly stored dose of ROTATEQ vaccine vial (lot # R016790, expiry date was 20-APR-2020) (route of administration, strength, dose, frequency, dose number were not reported) which was administered after temperature excursion (product storage error) for prophylaxis. No symptoms were reported (no adverse event). The vaccine was exposed to 47.3 degree Fahrenheit (degrees F) for time frame of 18 minutes. There were no previous temperature excursions reported. The call was because of a data logger. No product quality complaint was involved. No additional information has been reported.
Her breathing is little bit labored; Chills; This is a spontaneous report from a contactable consumer (Parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that patient got the 2nd shot, 12 hours ago and she just woke up and told me that she has the chills and her breathing is little bit labored and consumer was trying to figure out should consumer get her to the hospital or not. The outcome of events was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I have been experiencing a rapid heart beat and tightness in my chest, since I got the second vaccine. I haven't gotten booster yet. Once I tested positive for COVID-19 last Tuesday, I had tightness in my chest. I still feel it and I don't know if it's in the lungs or the heart, but I feel like something is going on. I am trying to take it easy and not strain myself. I am staying home from work and isolating myself until Monday January 3rd. Hopefully it's nothing, but I just wanted to make you aware of it in case something happens that is heart-related with me. I would definitely say its linked to the vaccine and/or catching COVID-19 or both.
SEVERE ARM PAIN/ACHE/SORENSS WITH OCCASIONAL BURNING NOT RELIEVED BY TRAMADOL OR ANACIN. NOT GETTING WORSE AS OF THE DATE OF THIS REPORT
I am only reporting so that there is a record of outcome for people with MS.  My first shot on 2/25/21 resulted in headache general feeling of not feeling well on 2/27.  My 2nd dose on 3/25 resulted in my insides trembling for about a day, feeling cold but sweating, severe headache.  I have only had this trembling inside feeling one other time and it was when I had food poisoning.  It is like you cannot stop your insides from shaking.   That was only 12 hours after vaccine and lasted all night.  3/26 was still feeling lousy, headache and trembling that came and went, and dizzy off balance feeling.  Which is not unusual for me, but much more intense.   I slept frequently.   3/27 - today I am still having slight headache but feel I am on the mend.  Taking Tylenol for headache the whole time seemed to help.  Just wanted to give input for people with MS.
Legs not working. Unable to stand or walk; Legs not working; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 12:45 (Batch/Lot number: unknown) at the age of 78 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: Diabetes mellitus (unspecified if ongoing). Concomitant medication(s) included: TRULICITY. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 78 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 78 years old, for Covid-19 Immunization, reaction(s): Legs not working, Unable to stand or walk. The following information was reported: immunization, gait disturbance and limb discomfort with onset 08Dec2021, outcome recovered (Dec2021). The events legs not working. unable to stand or walk and legs not working were evaluated at the emergency room visit. Therapeutic measures were taken as a result of gait disturbance, limb discomfort. Additional information: Seriousness criteria was life threatening, results in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Fluids for dehydration after dose 2 were given as treatment. The lot number for bnt162b2 was not provided and will be requested during follow up.
From initial information received on 16Jan04 from a physician regarding an adverse event occurring, it was reported that an eight year old male pt received Fluzone SV 2003-2004 USP, lot number U1148EA, administered IM on 09Jan04. Two hours post immunization, the pt developed funny movements of his hands and face, with some slurred speech. The pt was seen by a physician. These events still persist and he is being evaluated by a pediatric infectious disease specialist. From additional information received on 30Jan04 from, it was reported that a couple of hours after the vaccine was given the pt's lips swelled up. He did not have difficulty with breathing. Subsequent to that, he had an exacerbation of what was observed to be facial ticks. He also had some finger rolling bilaterally that seemed to be voluntary. He did not run a fever, he had no sensorium changes and there were no difficulties in school. The pt has had a past history of asthma and was on Advair daily including the day of vaccine. After the doctor examined him at the visit, which was routine third grade visit, he seemed congested so the doctor suggested that he be started on Albuterol inhalations. The mother gave him the first dose after they got home a few hours after the injection. He has been on that daily at least once or twice a day as well as Advair until one day ago. It is unclear how long pt has had these apparently nervous type ticks, however the family and teachers have noticed an increase in the ticks and finger rolling episodes. The pt does not seem to be particularly anxious or bothered by these things. He had not had any caffeine or chocolate during the week prior to examination by the pediatric infectious disease specialist on 16Jan04. At that time, the ticks had decreased and the hand rolling episodes had ceased. The pt's mother felt that he was back to usual self. At the visit it was noticed the pt's father also had some facial ticks and grimaces mainly involving the eyes and the lips. The family's interpretation is that with stopping the albuterol, whatever reaction was going is certainly much less. His physical examination was unremarkable with the exception of a slightly elevated blood pressure of 125 in the left arm and 127/68 in the right, possibly due to anxiety. Neurologically he had intermittent facial ticks, mainly closing one of his eyes and grimacing. He had no dysarthria or any overt neurological deficits. During the examination, he had one episodes of pill rolling, which the family has described as the movement of his fingers into the palms bilaterally. The physician felt that this seemed to be voluntary. The pt's motor function appeared fine and he was developmentally and psychosocially intact.  The physician's assessment is this was a possible allergic reaction to the influenza vaccine, as characterized by the swollen lip compound by antiasthma medications, particularly the albuterol, plus anxiety after the injection leading to an exacerbation of an underlying process of facial ticks with some unusual movements of the hands, but which have now subsided.