chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer referring to his or her 10 years old son. In approximately 2006, when the patient was 1 to 2 years old, he was vaccinated with VARIVAX (Merck) (lot number, dose, and route were unknown). On 25-FEB-2015 the patient was diagnosed by his pediatrician with shingles. The outcome of shingles was unknown. The causality between shingles and VARIVAX (Merck) was not provided. Additional information has been requested.
t103, lethargic & change in personality x 1-2 days per mom's report; Gave DT 8JUL91;
SICK NOW; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sick now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick now. This report was non-serious. This case was associated with a product quality complaint: 90000261952 This case, from the same reporter is linked to 20221210446, 20221210598, 20221210980 and 20221211116.
First, my heart raced, then I felt flushed, then my throat and tongue swelled to point I could not swallow or breathe freely without sticking my tongue out of my mouth.  I took benadryl liqui-gel and waited to see if it would kick in. It took about 25 minutes for my tongue to go down to the point where I could fully swallow. My throat remained so swollen I looked like a frog for 36 hours and, now after about 52 hours, it is finally going down. It's still swollen, but not in an obstructive way.
Dizziness; initial BP 186/89 (pulse 50). F/u BP 178/64 (pulse 54).
Internal body vibrations beginning in July 2021, starting in my feet and moving up into my body, arms and hands with stress.  My hands lose fine motor control when the vibrations get very bad.  They are idiopathic. I can allieviate them for a few hours with sports mineral and electrolyte supplements.
Patient received vaccine 27 days ago and noticed about a week after receiving shot that she started experiencing pain and random burning sensation.
Onset - 9/28/18. Awoke and arm (R-deltoid) red and warm over site. Size of reaction 75 x 75 mm.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with GARDASIL. Subsequently the patient fainted. The patient had sought the nurse practitioner for medical attention and recovered (date unspecified). Additional information has been requested.
Little sore; He started to feel tired and have no energy; He started to feel tired and have no energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (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 (non-serious) with onset Aug2021, outcome "unknown", described as "Little sore"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset Aug2021, outcome "unknown" and all described as "He started to feel tired and have no energy".  Additional information: The patient decided to get the first Pfizer shot of the vaccine last Friday which was on 06Aug2021. So, everything was fine, just a little sore like the flu vaccine but then that day, he started to feel tired and had no energy. The patient had experienced some side effects. So, he wanted to know how long did the side effects of the vaccine last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initially started as slight arm soreness in the hours immediately after the vaccine. Woke up in the middle of the night Thursday morning with nausea and dry heaving along with severe joint pain in the ankles, knees, shoulder, lower back, and wrist, chills, and shivering. Had a low grade fever the entire day Thursday and into Friday despite taking acetaminophen. Joint pain was barely relieved  by Tylenol.  Arm and joint pain still persistent. Slight sore throat also present. Also pain sensation seemed to be heightened. Putting lotion on was painful, others touching my skin was painful, etc. The highest severity of symptoms was on Thursday but are persisting into today.
On Aug. 15, 2007 my daughter had what the emergency room listed as a seizure. Around 9:45pm she woke up, quiet type scream and crying, my husband and I tried to wake her and she would "stare", like she wasnt there, or right through us, she would not or could not respond to us.  She cried and turned on her side. We thought she was having a bad dream or had a leg cramp.  We asked her what was wrong, no verbal response, staring, for about 5-10minutes. I felt her head, it was "clamy", and I noticed she had "drooled" and the left side of her face was "droopy".  My husband called 911 and I kept asking her questions to get a response. She did try to respond, but it was like her tongue was "fat", because she was just mumbling, not real words.  The parmedics came and started an IV/did all the tests and suggested we go to emergency to get everything checked out.
Acute inflammatory demyelinating polyneuropathy; tested positive for COVID-19; tested positive for COVID-19; This is a literature report for the following literature source(s): (privacy).   Case Diagnosis: 75-year-old male with a presumed resolved COVID infection who developed Acute Inflammatory Demyelinating Polyneuropathy (AIDP) weeks after an initial dose of the Pfizer vaccine. Case Description: The patient had a COVID-19 infection that did not require hospitalization, presumed resolved, and received an initial dose of the PV three weeks later. He presented to the Emergency Department (ED) three weeks after his initial dose with bilateral symmetrical weakness of all extremities, distal limb paresthesias, and impaired proprioception in his toes, and discharged home. Two days later, he presented to the ED for worsening symptoms and gait instability, tested positive for COVID-19, and was admitted to Neurology for AIDP in the setting of persistent COVID- 19 infection as opposed to a response to the vaccine itself. Due to recent anticoagulation use, lumbar puncture was deferred and he was treated with five days of empiric intravenous immunoglobulin (IVIG). Electrodiagnostic studies showed sensorimotor polyneuropathy with axonal and demyelinating features thought to be early signs of AIDP. He developed hyponatremia that spontaneously resolved. Patient was admitted to AIR at moderate assistance level with an assistive device.  Setting(s): Acute inpatient rehabilitation (AIR). Assessment/Results: This patient developed AIDP three weeks following PV administration after having a presumed resolved COVID-19 infection, but still tested positive on admission. Symptoms improved with IVIG and therapy focused on impaired sensation, endurance, strength, and balance. This patient was discharged home at an independent level.  Discussion(s): AIDP is an uncommon complication of COVID-19. Treatment typically includes IVIG along with a potential rehabilitation course as guided by a physiatrist. It is imperative for physiatrists to diagnose AIDP as a complication of COVID-19 exacerbated by administration. Conclusion(s): AIDP is a potential complication of COVID-19 infection exacerbated by administration and may require acute inpatient rehabilitation to address patients' resulting functional deficits.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event lack of effect (COVID-19) and acute inflammatory demyelinating polyneuropathy with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
3am headache until 5pm, 11am vomiting 3 times, 12am vomiting 2 times. weakness. All the same day.
Developed rash 8 days after receiving MMR and VARIVAX. Rash is diffuse on legs and trunk. There is swelling of hands and feet. Dx'd with erythema multiforme. No mucous membrane involvement. Also has had fever for 2-3 days (up to 101.1) Rx'd BENADRYL and Acetaminophen.
Immunocompromised 5 yr old received DTaP and IPV Rt thigh and MMR left thigh to complete childhood series.  Rt thigh 2nd day red with golfball size swelling (used ice and tylenol) 3rd day temperature, swelling size of baseball, red and hard.  Family physician dizgnosed cellulitis and prescribed oral antibiotics.  Mother reported to clinic on 8/5/03 AM, stating was improvement with medication.  Appears to be cellulitis.
Exhaustion induced headache. I was going for a jog, and the headache was so bad that I had to walk half a mile back. And on a scale 10 if I was to rate it, it will be a 9. Mild head before going for the jog. But the pain increased a I jogged. Fatigue, sore arm.
On 07/05/2001 pt presents with about 10 cm area of redness and warmth around site of Pneumovax injection received 07/03/2001. pt reports symptoms started within 24 hours of injection. She reports applying ice packs to the site and taking ibuprofen for discomfort.
A large, itchy, red rash appeared on the vaccine injection site approximately 10 days after the vaccine was given. It measured around 5" in diameter, was slightly raised and was not painful.
After taking second shingle shot I had one day of symptoms. Headache, dizzy, fever, body ache, eye aches,
Streak of redness from vaccine site (deltoid) to inner elbow (Right) warm to touch treated with AUGMENTIN. Course of Tx began today.
Numbness in my left arm and hand that started a few hours after receiving the vaccination.  I spoke with my Dr. on  Nov 23, and she prescribed using heat at the injection area and taking Ibuprofen. The numbness is almost continuous.
Pain; Nausea; stomach ache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 87-year-old male 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 stomach pain, pain and nausea. On an unknown date, the outcome of the stomach pain was recovered/resolved and the outcome of the pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, pain and nausea to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced stomach ache, pain and some nausea. The patient had contacted his HCP (health care professional) regarding the symptoms because he had experience the stomach ache and nausea for 3 days. No other information to report. The reporter consented to follow up.
Tinnitus mostly in  left ear; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL8982), via an unspecified route of administration in the right arm on 21Jan2021 at 10:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to sulfa based drugs. Concomitant medication included Vitamin D (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL8982), via an unspecified route of administration in the right arm on 30Dec2020 at 14:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Jan2021, the patient experienced tinnitus mostly in the left ear. The event resulted in [Doctor or other healthcare professional office/clinic visit]. The patient's ears were cleaned and given hearing specialist appointment. The clinical outcome of the event tinnitus mostly in the left ear was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Injection site swelling; Injection site redness; small bruise; stings strongly; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site bruising and injection site stinging. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site bruising and injection site stinging were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site bruising and injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient  experienced injection site swelling, injection site erythema, injection site bruising and stinging.  The patient want to know if need to be concerned. The reporter asked the patient to call healthcare provider for more information.
Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, two weeks following vaccination, the patient experienced pain at the injection area. The patient also complained of pain in the same area when lifting her arm. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Patient developed redness, swelling and  a "lump" at site of of injection 2 days after vaccination. Her right arm was sore and swollen for the following 5 to 6 days. The lump was approximately the size of a "fifty-cent piece" following the injection but decreased in diameter over the course of 2 weeks. The lump was size of "pea" on 06/05/2019.
Diabetic with ulceration on foot, now has cellulitis. Saw foot Dr., seeing ID, to see PMD 10/23/12. 10/25/12 Client is being treated for cellulitis in leg not related to flu shot.
Approximately 6 months after my booster shot (Dose 3) I tested positive for COVID-19 and experienced the following symptoms: Cough, Runny nose, Congestion, Fever, Body aches, and chills. I took Ibuprofen for treatment about 3x per day for 1 day but it did not really help improve my symptoms so I had to call my Doctor for consultation and also to make sure that taking Ibuprofen was safe because I just recently gave birth and was breastfeeding my baby. The doctor advised me to take Tylenol, Flonase and Mucinex (which is safe for breastfeeding mothers). As of today 06/01/2022 - I just started taking all 3 medications stated above and have been feeling better except for my cough. I am still positive for COVID-19 as of today.
STABBING PAIN SO BAD PATIENT COULD NOT STAND THE PAIN-LITTLE SWOLLEN AREA WENT TO WALKIN CLINIC AND THEY DID NOT KNOW WHAT TO DO SO SENT HIM TO ER AND THEY DID NOT KNOW WHAT TO DO EITHER. HOT PACKS WERE BETTER THAN COLD PACKS, GAVE HIM 3 MOTRIN AND 2 TYLENOL AND SENT HIM HOME IN ASCURSIATING PAIN  AND TOLD HIM TO REPEAT EVERY 6 HOURS-PAIN SUBSIDED ABOUT 2 AM BUT IS EXTREMELY SORE AND HURTS  STILL AND CANNOT MOVE THE ARM UP OR OUT.
1st inj on 6/17/2008;2nd inj 8/19/2008; on 8/26/2008 pt presented to office with dizzines, tingling in hands to numbness and then slurred speech that happened while at school; when she presented to the office within 1 hour of onset, she had completely recovered from s/s; due to these s/s family defers further vaccination8/28/08-records received for DOS 8/26/08-Chief complaint-dizzy spells/tingling in hands and not able to speak well. C/O dizziness while getting up from sitting position. Neurologic exam, no focal deficit, normal cranial nerves-II-XII sensory and motor WNL. DTR 2 plus, gait normal, no cerebellar signs, no focal signs, normal strength, tone and reflexes, sensory test normal. Assessment: Near-syncope. Suspect orthostatic hypotonia trigger with possible hyperventilation as secondary. Follow-up as needed.
Vaccine 9/22/09 1st day great.  Second day arm stiffness and soreness.  3rd day on developed aching sensation in right upper arm and unable to abduct arm without severe pain (shoulder area).  Will wake up at night throbbing if raises arm above head soreness and aching goes away.
patient described as " Heart rate, felt like racing HR, anaphylaxis, tongue swelling, Felt like passing out"
C/o of pain at the injection site upon influenza vaccination administration. Local soreness and warm to touch at injections site. She was evaluated by her pcp and ruled out an infection. She continues to have limited upper arm movement.
2-3 days after receiving shingles vaccine, I had a large raised red spot on my left arm; spot was hot, itchy & lasted 6-7 days. I still have a brown spot on my arm.
1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradually increased. Before bed time, had cold sweats and shakes. 1/29 - woke up feeling perfectly fine.  2/17 - Second dose of vaccine. Arm felt sore and was sore two days after. From 2/18-2/20, I noticed the effects of the Cymbalta were gradually decreasing and was experiencing side effects (shocks from toe to head every step). Turns out that even with taking my regular dose of the Cymbalta, my body after 2 hours feels like I had never taken it.   2/20 - After experiencing heavy shocks, shaking, and heart racing, I went home after coming into work 3 hours later.  2/21 - Woke up today feeling dizzy, fatigued, and weak. I know that operating a motor vehicle will not be possible for me.
PHYSICIAN PRESCRIBED THE MONOVALENT DOSE INSTEAD OF THE BIVALENT BOOSTER DOSE FOR THE PATIENT.  NURSE GAVE MONOVALENT COVID DOSE INSTEAD OF THE BOOSTER.
This case was reported by a other health professional and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 20th September 2018, less than a year after receiving SHINGRIX and unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient received Flu shot of unknown brand. The case was linked to the case US2018GSK176949, reported by the same reporter.
nose was running yesterday too; This is a spontaneous report from a contactable consumer (Patient). This consumer reported for a female patient (reporter's mother),who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Patient's age at vaccination was not mentioned. The patient's medical history and concomitant medication(s) was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date, the patient experienced runny nose (rhinorrhoea) after administration of BNT162B2 vaccine. The caller asked if a runny nose was a normal side effect of the vaccine. Information on treatment taken is unknown. Outcome of the event is unknown.  Follow-up attempts are completed. No further information is expected.
rash/a rash all over his body; chest pain; pain at the injections site; itchy; This is a spontaneous report from a contactable nurse. A 12-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced rash/a rash all over his body, chest pain, pain at the injections site and itchy. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient's wife said injected arm was sore, red, and hot to the touch. Affected area from shoulder to elbow. Advised using Tylenol , cold pack, possibly Benadryl, and to call MD if getting  worse or not resolved.
patient contacted pharmacy indicating had to go to provider since could could not raise arm. also rec'd pneumovax 23 in same arm, right,lot t020638. said felt like it did when she had rotator cup surgery. at her provider visit he recommeded she report to us and felt he saw higher than expected injection site of one vaccine but this is verbally being reported to us from patient, not providr
vaccinated 1005 - walked to observation around 1008 vagal response in observation area - slipped to floor - attended  by paramedic -small brush burn above eyebrow - no lumps joint head or neck pain -   remained conscious throughout incident pulse bradycardic 40 - 50 C/O dizziness pale and sweaty - legs elevated - after 10 minutes symptoms resolved and patient assisted to her feet - symptoms returned - placed on stretcher legs elevated  - EMS notifed - transported to ED around 1028 BP on transfer 98/46
I had the shot like usual. Went back to work. In the middle of the afternoon, I went for a walk, outside. I began to become itchy. It was almost like a photosynthetic reaction. The itchiness was all over, on my scalp, my thighs, my back, my face.  It wasn't severe, but noticeable. It was definitely a medicine induced weird reaction, as I've had it before from other meds. It wasn't severe enough to seek medical attention. I'm still a bit itchy the second day. I've never had this reaction to a flu shot before. I get them annually since I work at a school.
Approx 12-18 hrs after 2nd dose of Moderna vaccine, had episodes of dizziness, syncope and sinus pause. Observed overnight in hospital with no recurrence and condition resolved by d/c. Pt is very healthy, cyclist capable of 30 mi qod rides with no issues.