chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/1/02, developed inability to smile; left facial Bell's Palsy and drooping eyelids. Saw doctor on 1/2/02 and was placed on Prednisone 80mg po and decreasing dose and acyclovir 800mg po 5 X ?. Sees MD on 1/16/02. Said Bell's Palsy unrelated to flu shot but pt said the F/U sheet said to report anything unusual.
At site of injection, hot, red, swollen approx. 1.5 inches across after 2 days post injection.
"very tender" (AE: Tender injection site).; her arm was hot (AE: Warm Injection site); fever; aches / Body ache; upset stomach; headache; fatigue / felt very tired; slept for 12 hours; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 16th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 1 days after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive. On an unknown date, the outcome of the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix. Next day after vaccination at evening patient had fever, aches ( Body ache) her arm was hot (Warm Injection site) and "very tender" (Tender injection site).  The patient also had upset stomach, headache, fatigue,felt very tired and patient slept for 12 hours. The patient reported that symptoms were resolved in less than 24 hours. Lot and expiration date were unknown. Agent failed to ask in which arm vaccine was administered.  The reporter consent to follow up.
pt received her second dose of the pfizer vaccine. as soon as she sat down for the 15 minute observation, she slumped over and fell to the ground. we called 911 and she was conscious. she needed about 1 minute to gather herself. Her legal guardian said she usually has anxiety after getting a vaccine. the EMS came in and took her to the hospital
After my 3rd shot, I had typical symptoms (slightly elevated temp 99.5, chills, fatigue, body aches). On 10/31 I started feeling itchiness on my scalp and hands. The next morning I could see the start of a rash down my neck, and was diagnosed with Urticaria. I have had this one other time when I was around 8 years old, and was told it was a reaction to the drug cechlor. As of 11/3 hives cover most of my body and my eyes are quite swollen.
Fevers for several days, nausea, diarrhea, myalgias/arthralgias., headaches, sweating, worsening R sided facial pain; these have been persistent for 1 week now
Patient received the 1st dose of Moderna vaccine at 5:30PM. Patient was advised to wait for 15 minutes and report to the pharmacy team know if there was any unusual reaction. At 5:40PM , patient informed that he was feeling flushy and he fell down immediately on the floor. I instructed my technician to call 911 immediately. He woke up 30 seconds after falling down and I was there to check on him. We observed him and offered a bottle of water. The 911 team arrived and did a few tests: measured blood pressure reading, collected the heart rate reading, performed the EKG and glucose test. After 20 minutes, patient was alert. He was able to provide answers from the 911 team correctly (his address, the city that he was from, the city that he was at, his full name)  and informed that he was okay to go home. The 911 advised him to have a few sips of Pedialyte and had a small snack. Patient reported that he had not eaten since the morning and had very few liquid.
I began to feel nausea, headache, body aches. I proceeded to have diarrhea. My temperature was 99.5 (I am usually 97). The symptoms began around 7 PM and lasted until the next afternoon.
Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09599. A 4-month-old patient received a PERTUSSIS VACCINE (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic, absence and hemiconvulsions, which were intractable to multiple medication trials. Developmental and behavioral issues were described as "regression age 1 year" and autistic-like features. Initial brain MRI results were normal. At 3 years of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (T4837C, Phe1463Leu) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized and focal discharges. Outcome was not recovered. Documents held by sender: None.
Redness, soreness swelling at injection site. Small quarter size rash on right thigh.
Sudden nerve pain made worse by stretching arm. Patient explains it as a tearing of the muscle sensation. Pain located about 5 inches south of the injection site on arm.
Moderna COVID-19 Vaccine EUA Ist vaccine - 24 hrs after dose I developed chills, headache and a fever of 102.  Symptoms subsided after 12-14 hrs. 2nd vaccine -12 hrs after dose I developed chills, headache, fever of 104.1, nausea, and extreme fatigue. Between the fever and nausea I became dehydrated as I couldn't keep anything down.  Fever broke about 16 hrs and symptoms subsided once I was able to rehydrate.
On January 19th, 2021, i received the first dose of the moderna vaccination right after the following day i began to feel pain in the area where the vaccination was given and i thought the symptom was a normal effect of the vaccination. On the 23rd of this month i noticed my arm began to increase in pain and became itchy.  27th Jan left workplace due to severe pain at vaccination site; went to urgent care clinic for examination. Redness, swelling and bump at injection site. 29 Jan pain spreading to neck and back area.
Patient describes soreness to right deltoid area after receiving flu vaccine on 11/3/06. Patient describes whole arm sore. Examined by MD on 12/1/06. DX- rt shoulder pain following flu vaccine. Tx- continue NDAIDS. F/u in 1 month if pain continues.
patient tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 2020. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment was provided.  No prior vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek any medical care (office visit, Urgent care, ER, hospitalized).  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure is also noted in the case and considered as an event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Investigations and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527132 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure is also noted in the case and considered as an event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Investigations and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
diarrhea; nausea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (nausea) 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.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
FAINTED SHORTLY AFTER RECEIVING THE VACCINE. PARAMEDICS RESPONDED BUT PT DECLINTED TRANSPORT TO HOSPITAL
Pt Right arm became sore to touch, hard to move, and there was a knot on her Right arm. Advised to do warm compresses. Use TYLENOL or MOTRIN.
Information has been received for the Merck Pregnancy Registry for GARDASIL from a 22 year old female consumer with no pertinent medical history or drug reactions/allergies who on 18-DEC-2007 was vaccinated with a first dose of GARDASIL injection. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The consumer reported that she received the first dose of GARDASIL while she was pregnant. The consumers LMP was 13-NOV-2007. The caller was admitted to the hospital overnight for 1 day for the flu. Medical attention was sought. There was no side effects reported as a result of her getting the dose of GARDASIL. On an unspecified date the patient had a diagnostic laboratory test and an ultrasound performed. Results were not given. The estimated date of delivery is 19-AUG-2008. No additional information was given. Additional information has been requested.
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 16 YEARS OLD AND JANSSEN 0.5ML DOSE IS INDICATED FOR 18+ YEARS. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN QUALITY ASSURANCE AUDIT.
Information has been received from a physician concerning an 8 year old female who on 28-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 654804/1258F). On 02-MAR-2007, the patient experienced injection site reaction which was cellulitis. Medical attention was sought. Subsequently, the patient recovered from injection site reaction which was cellulitis. No product quality complaint was involved. Additional information has been requested.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable, Janssen given as an alternative 9.15.2021.
PATIENT DENIES ANY SIDE EFFECTS MONOVALENT DOSE GIVEN - SHOULD HAVE BEEN BIVALENT - PATIENT WILL RETURN IN 2 MONTHS TO RECEIVE CORRECT VACCINE.
Two days after having his first COVID 19 vaccination the patient described new onset tachycardia while at rest that did not resolve with rest. He was seen by a cardiologist for an ECG which was negative for arrhythmia, patient has lab work scheduled but has not yet gone to have it drawn. Was still complaining of feeling tachycardia 3 weeks after getting vaccination.
after 30 minutes of receiving his Dose 2 of Pfizer COVID 19 vaccine.  Patient c/o palpitations and tightness of his throat. Denies any SOB/Chest pain/Pruritus/syncope. Able to tolerate clear liquids with c/o of dysphagia unresolving " my throat is feeling like it is tightening up. "
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
Sore arm after the Pfizer Covid Vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm after the Pfizer Covid Vaccines".  Additional information: Reporter stated that he works in an emergency room and a couple of patients had raised this concern. States he already called the CDC, and they gave him the numbers to call for Pfizer and Moderna. Reporter stated that he has had a couple of people with the alpha-gal reaction to a tick bite, which is where they develop a reaction to the dextrose molecule that gets injected and then when they eat red meat, they become anaphylactic per the caller. Reporter stated that he has heard from a few of them that they read on the internet that if you have the alpha-gal reaction and you get the Covid 19 Vaccine you will develop anaphylaxis and die. Reporter stated that the CDC told him they have no information on this, and no one has reported such a reaction. Reporter stated the CDC said they recommend taking the vaccine. Reporter stated he is just trying to find out more information on this, since he has been asked about it more than once. Caller verifies that no patients have received the Covid Vaccine and then had this reaction that he is aware of; they are just worried it could happen since they heard about it on the internet. Reporter stated that he is an advocate for the Pfizer vaccine. Stated that he had both doses of the Pfizer Covid Vaccine himself and then had the Moderna Vaccine for his booster dose. Reporter stated that with the Pfizer vaccines he had no issues, just a sore arm. Caller says the Moderna is the one that kicked his butt and had him sick as hell. Stated that he always tries to push people who ask him about the vaccines towards getting the Pfizer Covid Vaccine. Reporter stated that a sore arm is normal with any vaccine. Says the Moderna he had a 102-degree fever and felt like he had a bad flu. Reporter stated that as a Registered nurse in the emergency room the patient's often look to him for information and guidance more so than the doctors; he is just trying to do some research for this question.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
? Pt reports severe muscle pain and aches, predominantly lower half of body.  Used both OTC APAP and IBU, with minimal benefit.  Tried a Salonpas patch applied locally to where there was pain, with a little improvement.  Pt admits high pain tolerance, but muscle pain/ache was bothersome throughout day and night.  Started night of vaccine administration.  Not localized pain.  Pt denies fever, SOB, rash.  Possibly a little bit of nausea but could be secondary to increased APAP and IBU intake.  Seems to be decreasing but still painful, as of 2 days post vaccine.  Pt advised to monitor 1 more day.  Pt counseled to continue with OTC.  Call MD if worsens today 1/29/2021, call before end of business day.  Pharmacist to check in with pt on weekend to see if improving (i.e. decreasing pain level).
"Felt funny", fatigue, chest tightness. BP elevated, tachycardia flushed, severity fluctuated.  Seen in ER - BP/Pulse elevated with intensity of chest pain, fever 101, Tordal IM, NTGX2, Felt bad x 3 days.  Low grade fever 1st week.
excruciating pain in her spinal stenosis, pain is from bottom of her cervical spine to her scapular; Outside of her right arm to the 3rd, 4th, and 5th finger is numb and tingling; Outside of her right arm to the 3rd, 4th, and 5th finger is numb and tingling; Right hand is weak, she has difficulty holding a fork or a pen; A spontaneous report was received from a consumer concerning a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular, the outside of her right arm to the 3rd, 4th, and 5th finger is numb, the outside of her right arm to the 3rd, 4th, and 5th finger is tingling, right hand is weak, difficulty holding a fork, difficulty holding a pen.  The patient's medical history was spinal stenosis. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular (medical significant), the outside of her right arm to the 3rd, 4th, and 5th finger is numb, the outside of her right arm to the 3rd, 4th, and 5th finger is tingling, right hand is weak, difficulty holding a fork, difficulty holding a pen.  Laboratory details as reported included magnetic resonance imaging.  Treatment details included arthritis Tylenol, steroid, control drug.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular, the outside of her right arm to the 3rd,4th,and 5th finger is numb,the outside of her right arm to the 3rd,4th,and 5th finger is tingling,right hand is weak,difficulty holding a fork,difficulty holding a pen was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. An underlying history of spinal stenosis is a strong contributor.
Approx. 30 days after the nasal vaccine for H1N1. I had a sudden onset of bilateral shoulder, arm, elbow, wrist pain (R) worse than (L). Swelling of hands (it has lasted months).
Haven't had a cycle since the shot. Also had a severe case of dymenthia eczema on the bottom of my feet for 4 months. Never had it before.
Patient says that she started having neck pain the day that she received the vaccine on 10/14/19. Patient called pharmacy on 10/18/19 to alert us of this adverse reaction. She says she has tried heating pads and cream to help with the pain to no avail.
Four days after receiving the 2nd dose of the vaccine, a warm, red, inflammed area developed on my upper right arm.  As the day went on, other areas of my skin (left arm, same spot) such as my knees, ankles and inner wrists also developed this warm rash.   Later that evening and throughout the next day, the rash intensified in warmth and began to itch.  The rash spread over various parts of the body (hips, thighs, backs of legs, feet, palms of hands, forearm, chest, shoulders and back).  The worst period of the rash (the most intense burning and itching) was when it spread across my upper back and shoulder area.  I took ibuprofen for the inflammation and then combined that with a antihistamine for the itching.  The only relief (for about 4-5 hours) was this combo of ibuprofen and a antihistamine.  Continued this regime for three days in total.