chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 year later injection site had a bubble that never went away; t started oozing dried dark puss today until the small bubble went away completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 at 12:00 as dose 2, single (Lot number: Fc3181) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Red and green dye" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensative to Elm, elderberry, corn. Rice and milk; "Known allergies: Sensitive to Elm" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Known allergies: elderberry" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Known allergies: corn. Rice" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Known allergies: milk" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0181, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM, When the 1st shot was given, I felt extremely tired and sleepy. My arm also hurt for days.), administration date: 23Jul2021, when the patient was 43-year-old, for COVID-19 Immunization, reaction(s): "felt extremely tired", "sleepy", "My arm also hurt for days". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 03May2022 at 15:00, outcome "recovered", described as "1 year later injection site had a bubble that never went away"; PURULENT DISCHARGE (non-serious) with onset 03May2022 at 15:00, outcome "recovered", described as "t started oozing dried dark puss today until the small bubble went away completely". Therapeutic measures were not taken as a result of vaccination site mass, purulent discharge.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications Seamoss the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Injection site red, swollen, warm to touch. Patient experiencing chills, fever, headache. Applying ice to site and taking ibuprofen. Patient will call doctor if not feeling better or feeling worse by tomorrow.
48 hours after vaccine developed macular papular rash on right lower leg. Leg was also reddened in patches and warm. Toes/feet also a little reddened and swollen (especially big toe). Swelling decreased in 48 hours but at 96 hours rash is still present. Unknown if itchy or painful due to paraplegia.
No additional AE reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 20-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
pt recvd vax 25SEP91 & 24 hrs later pt devel fever between 102 to 105 as well as enlarged ax lymph node on the side of the inject; also devel lump & erythema @ inject site;
I started having issues in the stomach like pain and heartburn. Anytime I was eating regular food I was having issues with digestion and felt like I had burning in the stomach. I begin to eat very light foods to avoid this. The symptoms lasted for about 3 weeks. I contacted my doctor around April 20th and possibly had a telehealth appointment. By the time we spoke I was feeling better, so I don't remember if he prescribed anything. I was using a product that I purchased in Italy which worked well for treating the symptoms.  I started feeling better by the end of the month. Over the next year I had off and on issues with heartburn and indigestion.
Patient developed dermatologic reactions. Patient experience pain, redness that spread around upper arm, itching, slight swelling. Patient came to inform pharmacy about her symptoms but says symptoms were improving. Patient was given over the counter home care recommendation to help with symptoms and was advised to seek medical help if symptoms worsened.
Symptom onset began one week after vaccination. First symptoms were extreme sensitivity in both hands and inflammation, cracking, erythema, soreness of cuticles on all fingers on both hands. Was seen  by NP at primary care office, was misdiagnosed and recommended to soak hands in warm water.  Went to Urgent Care about a week later, because problem persisted and new symptoms of Scalp itchiness, redness, sensitivity of scalp started.  MD told patient to see a dermatologist. Patient made an appointment with a dermatologist, Dr., has blood work, scalp biopsy, examination, allergy scratch testing done. Diagnosed patient with dermatomyositis, which was confirmed with Dr. and second Dr. Started patient on hydroxychloroquine. Later was started on methotrexate. Patient was referred Dr. and started IVIG therapy. Symptoms persist despite these treatments.
Itching starting on right arm and spreading to back reporting 6 days after vaccine given. Follow up 11/12/2018 and itching reported to be diminishing.
Have developed on-going  asthma-like symptoms including cough and tightness when taking deep breaths. Treated with Proair inhaler and decongestants. Recently prescribed steroids and antibiotics
I am 67 year year old physician and have been inline distance skater for more than 30 years. I normally skate 3-4 times per week ~ 15 miles over about 90 minutes. I only walked for the two days after I received the  vaccine (about 5 miles each time )and developed some low grade myalgias following which responded to 600 mg. of ibuprofen. On December 26, 2020 (approximately 72 hours post vaccination) I skated about 15 miles and upon returning home developed  more intense systemic myalgias, nausea, fatigue, and general malaise which lasted about 12 hours. Today (December 27), the myalgias resolved. I have never had anything like this before. Since I see firefighters in my practice on a regular basis (as well as other first responders) I was concerned that coincidentally I actually developed Covid. I feel fine now but will get a Covid test on December 28 through my office. Curious if others reported similar side effects after the vaccine with vigorous exercise?
Note: Not sure if this is the name of the flu vaccine that I had at the same time. I had severe upper stomach pain; nausea; dry heaving; altered mental state - went to ER hospital - they tried to rule out diagnosis; turns out my thyroid was extremely elevated. Dx'd as Hypothyroid - I have follow up to do to definitively determine this. Medication for symptoms at this hospital  - Pepcid; Mylanta; Tylenol; Sumatriptan for migraine. They sent me home with an adjustment on my Thyroid Medication - adjusted it down. Feeling better but have a ways to go.
Patient reported feeling lightheaded and his ? heart felt like it was racing? Patient seen by medical team and provided water Patient?s symptoms resolved and refused medical transport and signed AMA form Patient will be driven home by spouse
Redness, irritation and swelling around both eyes.  Itching and burning sensation in both. Symptoms developed 3-4 days post vaccination.  Fast onset.  Consulted with Dr. via video visit.  Advised to use tacrolimus topical cream, antihistamine eye drops and other regular medications for reaction. Also advised to use Vaseline to moisturize and protect swollen eyelids, use cold compresses and monitor the symptoms.  Treated symptoms with advised solutions and symptoms gradually went away after 3-4 days.  Same reaction with 2nd vaccine dose, redness, swelling, and irritation of eyelids developed 3-4 days post vaccine.  Going about treatment in a similar manner, will again consult the Allergist office of the reaction.
Fell down + legs shook, 3 days post vaccination, Fever 102, Was given Motrin, Never got below 101 for 2 days (Mother thinks), 11/14/02 -Saw family physician who contacted a pediatric neurologist,  To stop pertussis.
Information has been received from a physician's assistant concerning a 31 year old female who was vaccinated with two doses of varicella virus vaccine live. At some point later (unknown time frame) the patient developed "full blown chicken pox" with over 60 lesions. No other information was given. Unspecified medical attention was sought. On 16JUN2003 it was reported that "this was not an adverse reaction to taking the vaccine". No product quality complaint was involved. No further information is expected.
little bit of rash on the chest and stomach area; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that Patient experienced little bit of rash on the chest and stomach area and it's now fading away. She wants to know if this is normal side effect of the vaccine and if she can have the 2nd dose. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Was given vaccines at 11:45 am.  Proceeded to front desk to get shot record. While in waiting room sat down and said he didn't feel well.  Passed out per mom's report. Nurse to front desk where pt. was vomiting, sweating and pale. Vitals taken: BP 120/82, pulse 80 resp. 13. Taken back to clinic, given a soda, observed for approx 16 minutes, was stable and went home.
Saturday, April 10 I experienced a hot, scratch throat, body aches and chills/low grade temperatures. Today, April 12 I noticed a red rash at the injection site which had been slightly itchy a couple times during the week. When I saw the rash I realized what the other symptoms were.  I am also having a flare up of my uterine fibroids in the same time frame. I don't know if this is related or coincidental. I am currently experiencing the above side effects.
PSORIASIS ON FEET; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drugs included: risankizumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriasis. On an unspecified date, the patient experienced psoriasis on feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with risankizumab was withdrawn. The outcome of psoriasis on feet was not reported. This report was non-serious.
USE OF EXPIRED PRODUCT (VACCINE OPENED ON 19-OCT-2021 AND ADMINISTERED TO PATIENT ON 21-OCT-2021); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 21-OCT-2021, the patient experienced use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021) was not reported. This report was non-serious.
Patient reported having significant swelling, soreness, and arm felt hot to touch and hard. Swelling decreased the next day but she still describes soreness below the injection site.
Dermatomal Rash appeared on 2/27/23, shingles in appearance, erythematous / vesicular cluster at epigastric region anterior / midline, extending under breast, then T1 posterior R arm pain with faint crusts seen on exam on 3/6/2023.  Given valtrex 1Gm TID x 7 days on 3/6/23.
No exact time course  provided.  Patient describes that since he has had the vaccine and also since he has started Dupixent 300mg PFS injections (in August also) he has experienced excessive hair growth on his knees, to point of it being bothersome and requires him to shave it.
Woke up this morning with chills, weak legs.  Have a low grade temp 100.0 F
Urticaria over trunk 6 hours after admin of DTaP, IPV, MMR, then swelling, redness of entire upper arm closest to MMR site.
Syncope, dizziness. BP 145/64, pulse 73, O2 sat 100%. 2 L Oxygen via nasal cannula given.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was unknown when the vial was stored in the refrigerator.  Vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contains non-significant information of secondary reporter was added.
Pt was given three vaccinations: Pneumovax 23, Zostavax, Fluzone HD on 11/4/2014 at around 1:15 PM. Pt presented back to pharmacy around 6 PM on 11/6/2014 with red, warm to the touch, oval shaped rash extending down from where shot was given in the deltoid of her left arm to her bicep. The patient also stated she had begun feeling "fluish" like symptoms with body aches. The patient was instructed to take Benadryl (25-50 mg) as soon as possible and to monitor rash. Pharmacy followed up with patient on 11/7 and patient states rash is almost cleared up and pt is feeling back to normal. Rash is no longer warm to touch and has lost its bright red color.
wrist started bothering her; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient's wrist started bothering her and she went to her wrist surgeon and received a steroid injection on 23Mar2021. She also stated that she received her second Pfizer vaccine dose on 24Mar2021. She received the steroid shot in her right wrist and received her vaccine dose in her left arm. The patient asked if she screwed up her second vaccine by getting the steroid shot the day prior. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever. Chills,  hallucinations,  renal failure,  ischemic colitis,  gi bleed,  blood clot,, dehydration
Swelling around injection site, swelling reached 3 inches in diameter within 24 hours of injection. Site was hot to the touch, itchy and painful. The morning of 4/8/2021 arm is still sore and a splotchy rash has developed.   2 benadryl and 3 advil were taken before bed on 4/7/2021.   As of 4/8/2021 there is trouble breathing which is continuing to be treated with albuterol nebulizer, wixela and albuterol inhaler.  2 benadryl will be taken before bed on 4/8/2021 as well as a dose of wixela and albuterol nebulizer treatment.
Patient under 65 years of age was vacinnated with FLUAD. Pharmacist in haste and without proper knowledge, thought she was vaccinating patient against flu but did not realize she was using an age specific product.
Events: Pain, Swelling, Fever, Localized redness of the skin Treatment: Went to PCP was treated and prescribed Benadryl, discussed with providers Outcome: after taking Benadryl, symptoms immediately were resolved
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Additional Details: patient had a 20 to 30 second seizure within 5 mins of getting the vaccine, patient reports extreme anxiety all day over vaccine and previous undiagnosed seziures that have been worsening
Patient was seated, given injection IM into right deltoid and immediately fainted and gave a jerk of the body.  Immunizing pharmacist yelled out for Rapid Response from the ER.  Emergency room staff was on scene within 1 minute.  They measured patients pulse and BP and took her to the emergency room for monitoring.  Patient was gone from immunizing area for 30 minutes.  She came back to see us, looking much better and said that she faints all the time.  She remarked she was glad she was seated because when she faints when she stands and hits her head she has a sore head for days.  She proceeded to schedule her second vaccination utilizing the QR reader we had provided to all patients.  Although she didn't tell us beforehand, afterward she told us she faints all the time, that it isn't unusual, and that she had deliberately eaten food and drank plenty of liquids before she came so that it wouldn't be a problem.  Patient stated that she was fine and fit to drive and unconcerned about the reaction.
Symptoms started 12 hours after vaccine given. Symptoms included: headache, fever, chills, joint pain, fatigue and nausea.  I was not able to work.  Symptoms stopped 24 hours later.
Cough; Fatigue; received the COVID vaccine on 2nd May, and she tested positive for COVID yesterday; received the COVID vaccine on 2nd May, and she tested positive for COVID yesterday; This is a spontaneous report from a contactable consumer ( Husband). A 53-year-old female patient received BNT162B2 (Solution for injection, Lot and expiry date: unknown), as dose number unknown, single, via an unspecified route of administration on an unspecified date in May2021 (at the age of 53-year old), for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the COVID vaccine on 2nd may, vaccinated, and she tested positive for COVID on 04Aug2021 and also experienced cough and fatigue on an unspecified date.  The patient underwent lab tests and procedures which included on 04Aug2021, SARS-COV-2 test: positive. No treatment was given for the events. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recv vax & devel a rash all over the body;reporting MD noted that pt was later seen by dermatologist who informed pt that rxn was not d/t therapy w/vax was strictly a dermatological problem;
BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of GARDASIL (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.