chrisvoncsefalvay/vaers-outcomes huggingface dataset:
63 year old male with progressive weakness at bilateral faces and extremities, LEs > UEs, absent DTRs throughout x 2 weeks. Received J&J vaccine at 3 weeks ago. His current neurological examination and clinical history is suggestive of GBS  NEUROLOGICAL EXAM:  MSE: A+Ox 3 Language: no aphasia   CRANIAL NERVES:  2nd CN: bilateral pupils are equal round and reaction to light, visual field-full 3rd,4th and 6th CN: EOM-I 5th CN: no sensory deficite 7th CN: face: symmetric, not able to smile or blowing air or holding water 8th CN: hearing loss: no 9, 10th CN: no dysarthria, palate movement:normal 11th CN: no neck weakness 12th CN: tongue: middle, no atrophy   MOTOR EXAM:  Tone: normal  Strength: 4+/5 at bilateral UEs, 4 Pt symptoms started very early. Narrative from family below:  "Day 1 (The day he took the vaccine): My father was complaining of very heavy chest pressure (said he felt like his chest was being pushed down with force.) He felt really tired and had a nasty headache.   Day 2 He began to feel tingles in his legs and arms. Said he felt sore and had mild pain around his back, feet, legs, hands, and arms. The headache came in and out.   Day 3 He began feeling more severe pains in both legs + headache. More tingling around his face, lips, and jaw.  Day 4 Severe pain continued around his entire body. Had an episode where he lost vision from 1 eye (he described it as blurry vision) felt like he was going blind from one eye.  Day 5 Could barely stand on his two feet and could no longer go to work. He stayed in bed and then hospital visits began. My mom took him to emergency for the first time.  I was able to get details of the location where he was vaccinated and onsite contact information. The info is below:
Pt has nasal flu mist approximately 10 minutes complained  S.O.B. BP 100/60 P80 R20 - color pale - wheezing gave EPI @ 145 P BP 94/60 P88. still pale and wheezing. Called EMT - P100 gave o2 took to ER.
LOW PLATELET COUNT; BLACK AND BLUES; This spontaneous report received from a concerned a 6 decade (age of patient (in late 50's early 60's) old female. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, consumer called to report that the patient got the vaccine and approximately 10 days later patient had black and blues and low platelet count. Patient was hospitalized and was still hospitalized on the day of reporting. Patient got a steroid and plasma treatment was used to successfully elevate platelets. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the black and blues and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210535373.; Sender's Comments: V0: 20210536558-JANSSEN COVID-19 VACCINE-Low platelet count, black and blues. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
sore muscle (deltoid) at injection site x 48 hours; better with Motrin sore lower back muscles x 72 hours; better with Motrin
Fever, chills, headache - started around 2:30  and fever resolved around 10:00 pm, headache persisted until morning of 12/14/2020.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, and concurrent condition were not reported. Concomitant therapy included sterile diluent (manufacturer unknown). From May 2017 until 22-AUG-2017, the patients were vaccinated with improperly stored of VARIVAX injection (lot # M036272 with expiration date of 17-AUG-2018 and M048203 with expiration date of 07-DEC-2018) subcutaneously for prophylaxis, which were stored under 15 Fahrenheit degree to 46 Fahrenheit degree (27.7 Fahrenheit degree) for 63 hours. There was no previous temperature excursion. And the call was because of digital data logger. Sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported.
mom stated approx 4 hr p/vax given pt had white film around lips, "starred" or cried inconsolably for 5 to 6 hr; also soreness @ the site of inj;
Red rash  with tenderness left arm on 1/26/2021, x 5 days.
I had sore arm on the first booster, fatigue extremely sleepy, second vaccination had zero symptoms. The Booster gave me fever, headache, vomiting.  Sickness went away after about 30 hours.
No adverse event occured We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
eye pain, optometrist said eyes had dry patches, prescribed moisturizing drops (non-prescription) was improving, occurring again after 2nd Vaccine on Feb 9th or at least continuing still putting in drops on Feb 23, planning to do follow up at eye doctor, still some eye pain
Next day post vax, the pt experienced a big pink circle on her bicep that dissipated down her arm in splotches to the elbow. The circle was neither raised, nor near the injection site.
Within 24 hours - redness and swelling at site after 48 hours - dizziness, hoarseness, fatigue.
itchy  small rash swollen warm to the touch below the injection  site 7 inches by 4 inches in size
Severe headache 20-30 minutes afterward. Turned to soreness and numbness at injection site by morning. Headache worsened to point of nausea. Whole body pain stiffness.
I experienced chills, muscle pain, feeling unwell, and injection site pain with heat coming from the injection site on the evening of my vaccine.  The day after my vaccine I felt tired, I had a headache, muscle pain,chills, and nausea.  On the third day of my vaccine I had redness, and swelling at the injection site, and soreness in my armpit area.
She had to go to the Hospital because she went into afib and then had a cardiac ablation; This is a spontaneous report received from a contactable Nurse from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; dofetilide (TIKOSYN), at 250 ug 2x/day. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: atrial fibrillation (hospitalization), outcome "unknown", described as "She had to go to the Hospital because she went into afib and then had a cardiac ablation". The reporter wants to know if there is any information about increased risk of Afib wile taking Tikosyn and receiving the 4th shot (second booster) of the Pfizer COVID-19 vaccine, she already received three shots of the Pfizer COVID-19 vaccine. She had to go to the Hospital because she went into Afib and then had a cardiac ablation, she has been taking Tikosyn ever since and haven't had another episode since she started taking the medication, she is also taking Eliquis. Her heart rhythm is normal currently. She is taking Tikosyn 250 mcg twice a day. She has read in "several places" that patients taking Tikosyn who receive a booster dose of the COVID-19 vaccine could go into Afib. She was not taking Tikosyn when she received the first three doses of the COVID-19 vaccine. Her cardiovascular Doctor who made her ablation might go with the CDC's recommendations. She has been two months out from her cardiac ablation. The patient underwent the following laboratory tests and procedures: Heart rate: heart rhythm is normal. The action taken for dofetilide was unknown. Therapeutic measures were taken as a result of atrial fibrillation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association and the information currently available, a causal association between the reported event and BNT162b2 and dofetilide cannot be 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 RAs, Ethics Committees, and investigators, as appropriate.
Pt noted itching in R inguinal area approx 12/17/04.  Vaccinated with smallpox 12/08/04.  Erythematous and lesion consistent with autoinoculation.
10/26/10 body aches especially both hip joints, front of thigh "feels like I ran all day"; also c/o slight headache - feel high "without really being high 4pm - employee feels much better.
1st dose on 14MAR2021.tested positive for Covid today.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Tested positive for Covid on 25Mar2021. Patient was scheduled for a 2nd dose which would be on 04Apr2021. She needed to be quarantined due to the situation. The event outcome for events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Pt came in the pharmacy on 11/26/14 complaining of redness, swelling, inflammation, difficulty breathing and anxiety (which he felt yesterday afternoon on 11/25/14).
low grade tinnitus; minimal hearing loss; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (low grade tinnitus) and HYPOACUSIS (minimal hearing loss) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A2A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TINNITUS (low grade tinnitus) and HYPOACUSIS (minimal hearing loss). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, TINNITUS (low grade tinnitus) had not resolved and HYPOACUSIS (minimal hearing loss) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Acoustic stimulation tests: abnormal (abnormal) minimal hearing loss.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included all kinds of supplements   This case was linked to MOD-2021-117061 (Patient Link).
Fever, body aches, HA mild diarrhea , fatigue . Tylenol with improvement.
Daily urticaria. The hives are random in timing and where they appear. They range from mild erythematous patches to raised white ridges within the erythema that are intensely itchy. They appear every 20-24 hours after taking an antihistimines. Pepcid and Claritin taken together help the most but the hives reappear every day regardless.
Treated by NP attending vaccine event.  HPI: Abnormal sensation in throat approx. 15 min after receiving  Moderna novel coronavirus vaccine. Denies SOB, wheezes, tongue swelling. No n/v/d, no abdominal cramping, no weakness, no faintness.  History of similar reaction to multiple medications.  In the past when she has had this throat sensation in reaction to a medication or food, she takes 12.5 mg of oral Benadryl and finds the reaction stops or progresses to hives to posterior knees and thighs, she typically takes more Benadryl and Zantac and the reaction ceases. One episode of anaphylaxis to oral sulfa. Hx hives reaction to one injectable for RA, cannot recall the name. No hx of anaphylaxis to injectable medications. Also reports remote history of severe episodes of hives of unknown origin over a 3 week period about 10-12 years ago; her provider speculated they were stress induced.  ROS: otherwise negative.  PE: Constitutional  - No acute distress. Speaks in full and lengthy sentences without difficulty. ENT: No oropharyngeal edema. Voice clear. No drooling. Airway patent.  Neck: Supple, no LAD, no masses, no torticollis.  Respiratory: CTAB, no increased WOB.  Cardiac: HRRR, no murmur.  A/P: Adverse rxn to vaccination, hx multiple food and drug allergies. Administer diphenhydramine 12.5 mg as she usually takes. Continue monitoring for extended period. Further intervention as needed, EM care if condition deteriorates.  Report to VAERS.  0918 - diphenydramine 12.5 mg oral administered. 0930 ? reports less fullness sensation in throat.  0935 ? reports abnormal sensation is completely resolved. Lungs CTAB, no increased WOB. No hives, no n/v/d, no faintness. No oropharyngeal edema.  0940 ? patient now questioning if she has reacted to the orange Juicy Juice she drank; she has never had one before.  1020 ? continues to be asymptomatic. Lungs CTAB, no increased WOB. No hives, no n/v/d, no faintness. No oropharyngeal edema. Discussed the importance of PCP follow up to be advised on whether or not a 2nd vaccine is prudent, she plans to seek this guidance. She may opt to rec the 2nd injection at the health department if her PCP advises it is safe, has been information on how to make an appointment there. Encouraged to seek re-evaluation for new symptoms.
pt recv vax & had brief period of apnea immed p/vax;recovered w/forced blowing into babies mouth causing pt to gasp;heart rate & resp were nl w/in a couple of seconds & was crying;mom reported pt slept 10hr w/o waking to eat p/got home;
Arm sore Fever Chills Nausea  Muscle and joint pain, hip pain  Tiredness  Dizzy
Information has been received from a licensed practical nurse concerning a female patient who was vaccinated with the second dose of Varivax one week after the first dose. The nurse did not report that the patient had any adverse reactions to this dosing. The reporter also noted that the patient had a blood test performed for seropositivity which was negative. A product quality complaint was not involved. Additional information has been requested.
In the first 72 hours: muscle pain, fever, exhaustion, headache, nausea After 72 hours: pain radiating down my arm into my thumb to the point I can't bend my wrist without shooting pain.  Urinary tract infection, then an ear infection, then a sinus infection.  Persistant sores in my gums. Exhaustion.  Food tastes strange.  Difficulty regulating body temperature--hot flash then chills.  Overall muscle stiffness.  Daily headaches.
Usual, expected side effects for a day or 2. Flu like, chills, temp, headache extreme fatigue, muscle aches. Severe headaches and extreme exhaustion, lethargy, occasional temp,  first identified at the beginning of April. Difficult in daily functioning.
On or about November 27, 2019, I noticed facial pain. By November 29, 2019, shingles rash began developing in the right side of the face, from the right corner of the lip through right nostril, right eye lids, top of the nose between eyebrows, right eyebrow, and continuing to the upper scalp. By Monday December 2, 2019, I had a full-blown case of shingles.  I was prescribed Acyclovir 800 mg/5 per day for fifteen days.
profuse sweating less than 2 hours after receiving the shot.  swelling and tenderness at shot site 12 hours or so later continuing to 3/2/2021
01/15/2021 had constant headache for 2 days. On 1/22/2021, had itching and developed rash/redness around injection site.
Patient came to pharmacy on 6/15/2012 with a rash at the vaccine site.  It appears to possibly be a varicella-like rash.  Patient stated it was warm to the touch and itching. Counseled patient to cover with a bandaid and apply cool compresses.  Also told patient to contact Dr but she did not want to do so.
The symptoms i have endured are from my left wrist to my neck then down my left side to my hips is in excruciating pain. My left breast and ribs under it feel as though I have been stabbed. My left arm pit stings and hurts when touched. I am starting to bruise along my left side and my left breast. My left arm is swollen and feels paralyzed   The pain started around 4:00pm on January 24, 2022. The pain got worse as the night went on. Any move I make puts the pain into power mode.
had T 99.6, pain in joints, inflammation of joints (redness, swelling, tenderness), Seen by MD, neuritis, neuralgia, paresthesias
Painful injected area aroun injection g-te 8cm x 8cm.  Is taking bendryl
Patient began feeling tingling sensation and tightness in chest. Denies difficulty swallowing, swollen tongue, or shortness of breath. States he feels like heart is racing. Lungs auscultated and BBS clear. EMT in attendance. Patient declines w/c to private observation area. Patient called wife to come into vaccine building (she is outside in car).  1630: HR 113; O2 sat 99% 1632: Patient having vigorous tremors. Fingers cold to touch. Gave Benadryl liquid 20 mL/50 mg PO. Patient declines ambulance transport. Patient wants to go home with wife. BP 158/98. 1635 wife in attendance. Wife states he will not want to go via ambulance. Strongly recommended that patient transports via ambulance. Recommended that patient go to urgent care clinic or ED for further evaluation. Wife went to bring car to exit area.  1640: O2 99%, HR: 105; no shortness of breath noted. Patient remains alert and oriented, still having tremors.  1645: convinced patient to go outside in w/c for fresh air. Patient agreed and taken to private observation area out back door. Patient removed mask and patient encouraged to deep breath. Upper body shaking continues. Hands remain very cold.  1650: patient's wife returned. Wife states she will take him to an urgent care area. She states she also has an epi pen if he worsens. She states if he improves she will take him home and monitor him. Patient declined w/c transport to private vehicle.  1655: patient left ambulatory with wife, no shortness of breath. Continues to shake.
PLAQUE PSORIASIS;  WENT TO DERMATOLOGIST ON 5/13/21 WAS GIVEN CREAM TO PUT ON AFFECTED AREAS 2 X PER DAY. I HAVEN'T BEEN  DISICPLINED WITH THE REGIMEN, AND MOSTLY PUT ON AS NEEDED FOR EXTREME ITCH. PSORIASIS STILL PRESENT (AS OF 9/20/21
t103.7; violent vomiting from 1-5AM 15APR92; pt had been on APAP q 4-6 hrs & still had fever; seen by MD @ 1015AM 15APR92; also local redness both thighs-cold compresses were applied;
30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee developed itching and red splotching (not elevated) on her left arm. She had no difficulty breathing, no swelling and said she "felt fine" except for the itching.  She took Allegra about 1:30 pm.  We recommended she call her husband to come and take her home and to go to ER if symptoms progressed.  She declined. At about 3:00 pm redness was improving on upper arm but had spread down to the palm of her hand.  Again she stated she felt fine. Patient drove home on her own about 4 pm but agreed to text Nursing Supervisor when she got home.  She reported at about 7 pm that she was greatly improved.  Follow up today (1/21) itching/redness is gone but does have body aches and headache.  Her only known past allergy is to Sulfa drugs. No issues with first dose. Let employee know that if there is ever a reason for another covid vaccine that she would have to have it done in the care of a doctor's office.
My period started May 28 and my second vaccine was May 29. I found out I was pregnant June 27 and had a miscarriage on July 12. Not sure if this is related but my OB wanted me to report it.
On 17APR about 2AM had high pitched cry lasting 3 hrs; tempra given & pt subsequently slept;
pt recv vax & approx 2 months later devel pneumonia & was hospitalized; p/unspecified testing, was dx w/influenza type A; tx & length of hospitalization were not specified; pt has been discharged from the hosp
Patient tested positive for COVID-19 greater than 14 days after second Pfizer COVID vaccination
SHAKINESS; PAIN IN HER CHEST; DIARRHEA; FEVER; HEADACHE; HIGH BLOOD PRESSURE; LYMPH NODES WERE INFLAMED; HEAVINESS IN ARM LFT INJECTION SITE; CANT MOVE LEFT ARM; SWELLING AT INJECTION SITE; EXTREME FATIGUE; PAIN ATA INJECTION SITE; A spontaneous report was received from a Healthcare Professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain at injection site. heaviness in arm left inject site, can't move left arm. On 16 Jan 2021, the patient experienced the events worsened heaviness in left arm. worsened pain at injection site, swelling at the injection site. On 17 Jan 2021, the patient experienced the events extreme fatigue . On 20 Jan 2021, the patient experienced the events high blood pressure. fever, diarrhea, shakiness. On 21 Jan 2021, the patient experienced the events lymph nodes were inflamed . On 22 Jan 2021, the patient experienced the events pain in her chest. pain in the back of her neck, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache was not reported.
Flu symptoms: aches, fatigue. Pt took Advil (400 mg) every 6 hrs.
She stated she felt hot on her hands while waiting after getting the shot and drank some water. She felt better and fine after 15 minutes so she left (12/10/18). She called the next day(11th)  saying she had nausea and diarrhea on the same day and discussed, consulted. I called her after finishing my shift (11th) and she said she started to feel much better. Sshe was advised to get medical help if it get worse and she said she was doing better.
Hives located on left thigh area over to left buttocks. Symptoms included an approximately 5" x 10 " rectangular area of hives with persistent itching (red blotches and welts) for a period of three days; also itchy eyes with watery discharge during same three day period. Treatment included cold water packs, administering Calamine lotion to affected area and the taking of Advil tablets. Per follow up: Our office did not report a reaction.