chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT DEVELOPED SHINGLES DAY AFTER RECEIVING 2ND BOOSTER SHOT OF MODERNA.  DIAGNOSIS WAS CONFIRMED DURING TELEMEDICINE APPOINTMENT WITH DR. PATIENT HAD PAINFUL RASH ON BACK AROUND BRA STRAP AREA.  GIVEN 7-DAY COURSE OF VALACYCLOVIR 1 GRAM TID.  AND GABAPENTIN 300MG TO TAKE AS NEEDED FOR NERVE PAIN
Left leg from thigh to knee, swollen with slight redness at medial aspect. None at injection site but increased heat. Some tenderness to touch.
The injection site was red, painful, and swollen. On Friday (12/24/21) after the shot in measured 11 cm by 7cm. The pain occurred when the limb was moved or touched. The swelling subsided by 12/28/21 but did leave a bruise when it subsided.
BLURRED VISION; HEADACHE; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, back pain, anxiety, non alcohol user, and non smoker. The patient experienced drug allergy when treated with morphine, and tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone hydrochloride/paracetamol for back pain.  On 08-MAY-2021, the subject experienced blurred vision. On 08-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and had not recovered from headache. This report was non-serious.
she had a problem with her hearing, eyesight and even with walking; she had a problem with her hearing, eyesight and even with walking; she had a problem with her hearing, eyesight and even with walking; She was diagnosed with Vasculitis disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "she had a problem with her hearing, eyesight and even with walking"; VASCULITIS (non-serious), outcome "unknown", described as "She was diagnosed with Vasculitis disease". Additional information: a consumer, would like to know if there is any other clinical testing that has affected Vasculitis disease. She mentioned that she got the Pfizer covid-19 booster. She mentioned that she had a problem with her hearing, eyesight and even with walking. She was diagnosed with Vasculitis disease and her doctor said that she was exposed to something the reason why she got the disease.  Follow-up attempts are completed. No further information is expected.
Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2015, the patient was inoculated at a Medical Center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a series of devastating complications, resulting in catastrophic total loss of her vision. On or about 11-FEB-2016, she sought treatment at center for visual interferences, described as "cob webs" and floaters in her vision, primarily on her right side. She was diagnosed with uveitis and elevated intraocular pressure (IOP) and prescribed prednisone. On 11-FEB-2016, she was also treated for iritis and panuveitus. On or about 16-FEB-2016, she sought treatment for worsening blurring and redness of her eyes and was prescribed prednisolone, TIMOPTIC and atrophine BID right eye for management of her painful eye complications. On or about 09-MAR-2016, she was treated for worsening vision in both eyes which was diagnosed as acute retinal necrosis, a condition cause secondary to herpes zoster keratitis, known as shingles infection of the eye. She was prescribed VALTREX in attempt to treat optic condition and was increased steadily in attempt of curb her necrosis. In April 2016, it was observed there was optic atrophy, nuclear sclerotis, obliteration of the retinal arterioles, and retinal detachment. Required surgery. On or about 06-JUN-2016, she was designated to be "legally and permanently blind" due to her zoster-related injuries and secondary necrosis. As a direct result of the vaccine, she suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition and irreversible blindness. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, uveitis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were determined a significant medical events. Uveitis, vaccination failure, nuclear sclerosis, iritis, acute retinal necrosis, herpes zoster keratitis, optic atrophy, obliteration of the retinal arterioles, retinal detachment required surgery, and blindness were considered disabling. Additional information has been requested.
Pt described injection site being red and hot (a typical reaction for her) but the redness started to spread down to her elbow by the 2nd day (not typical for her after a flu shot). She went to her doctor and was diagnosed with cellulitis and prescribed an antibiotic. It was clearing as of today 10/5/16 5:00pm.
I have recently had an EKG that showed an arrhythmia. I have never had any issues with my heart in the past. I think it is worth reporting. My doctor has sent a referral to a cardiologist to have it further evaluated.
pt recv vax 14JUN96 & 15JUN lt deltoid where shot was given began to itch;by 16JUN pt face was very swollen, had hives, & throat was starting to swell;taken to ER given a shot & IV & released
Sore/Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore/Achy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Sore/Achy). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, PAIN (Sore/Achy) outcome was unknown.            No concomitant medication provided.  Patient reported being sore and achy.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Developed epilepsy. Began having tonic clonic seizures. started on medicine. Seizures have yet to be controlled.
The night of 1st dose (on left arm), I had chills and fever, and my eye sockets felt some deep pressures when  I closed my eyes and tried to move my eyes up and down. Left arm was very sore. Two days later, I woke up with my whole face feeling "tight", looked at the mirror, it's swelling. I saw two "red bumps" on my left eyelid and one red bump on my right-side upper nose (near my right eye). In the afternoon, the bumps on my eyelid became itchy and turned into a reddish/pinkish patch, my left-side eyelid became swollen (the single bump near my right eye was gone). At the same time I notice my left-side upper lip was a bit swollen too. The following day afternoon, my right-side eyelid started a reddish/pinkish patch, and it became swollen too. Both of my eyelids are swollen at the moment- it's the 6th day after my 1st dose, and the 3rd day being swollen for my left eyelid and 2nd day for my right eyelid.
On 12-22-2022, I started having a sore throat, runny nose, headache and head congestion. I could not find a Covid test in my town. I started taking theraflu OTC. The next day, my symptoms had increased in severity so I went to the urgent care who tested me for Covid with positive results. They did not prescribe any medications. I quarantined at home and just continued with the theraflu, throat lozenges and mucinex. I am better today. I am reporting a breakthru case of Covid.
Information has been received from a physician concerning a female who on 16-JUL-2009 was vaccinated with the second dose of GARDASIL (0.5ml, IM). On 23-JUL-2009 the patient's mother called the office and stated that the patient's arm was sore and she could not lay on it or lift her arm above her head. The office mentioned that it might be the same patient that they had difficulty in giving the injection to (unspecified what kind of difficulty). At the report time the patient had not recovered. Follow-up information was received from a physician concerning a 16 year old female who received the first dose of GARDASIL (lot# 658271/0558X) on 18-MAY-2009. On 16-JUL-2009 the patient received the second dose of GARDASIL (lot# 662518/0087Y). There were no concomitant vaccinations. On 27-JUL-2009 the physician reported that the patient had some pain in the arm. The physician stated that it was unsure if the patient's pain was disabling. The patient's pain was not life-threatening and the patient was not hospitalized. Follow-up information has been received from the physician concerning a 16 year old (reported as 17 year old) female patient with no medical history who on 16-JUL-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot# 662518/0087Y) in her deltoid. There was no illness at the time of vaccination. On 16-JUL-2009 (previously reported as 23-JUL-2009) the patient experienced pain in her arm, and was unable to raise her arm and slept on side. The physician reported that there was still slight pain but had full range of motion. No further information is available.
Serious arm pain, painful to move arm, started to also feel tired and had some muscle pain in back extending to other arm around 7:30pm 4-6-2021  Woke up 4-7-2021 to all over body pain, fatigue, chills, felt feverish; injection site was swollen, red and burning hot; loss of appetite; felt sick the entire day till about 7:30pm   4-8-2021 only small amount of pain in arm that morning All other symptoms had cleared up
Fever, body ache, headache, vomiting, nausea, weakness, fatigue, dizziness.
not received the 2nd dose of Shingrix on time due to the pandemic/ dose on November 2019 / not received the 2nd one yet.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of shingrix, due to social problem. The reporter did not consent to follow up. This case has been linked with US2020216280, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216280:same reporter
Information has been received from a physician concerning a 20 year old female patient who on 21-MAY-2007 was vaccinated IM into the upper left deltoid with a third 0.5 ml dose Gardasil (Lot# 0211U).  On 21-MAY-2007, the patient felt faint after receiving the vaccine.  A few hours later, the patient's mother reported that the patient experienced pain that radiated at the injection site up her arm and towards her face.  The physician reported that the patient had pain up into her shoulder, radiating to her elbow and down her back.  The physician stated that this reaction was pretty minor and not serious however, he thought that patient was just scared.  The patient was treated with ice and ibuprofen.  It was noted no follow up was necessary.  Subsequently, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
My taste has changed in the past few days. Some items have become very salty all of a sudden For example, humus (that I  snack on every day) now tastes too salty to eat. The same with salami that I ate last week and couldn't eat more than one slice yesterday because of the suddenly too salty taste. Orange juice doesn't taste particularly sweet.  I made tacos last night and the flavors were dulled. Wine (same brand I always drink) now tastes sour; I've been craving cola instead. I looked on line to see if this was a a reported reaction to the Pfizer vaccine and saw that a "metallic" taste change was reported; I wouldn't call my taste change "metallic".
After 20-30 minutes from the injection i started to get the following systems of an reaction.   Restricted breathing (worse when lying down) Full body muscle soreness/aches Nausea Headache Sight location was red, swollen, hot to touch Fatigue
temperature of 101, severe chills, nausea, feeling very poorly overall, went to ER at the advice of an RN
Asthma like symptoms: Shortness of breath, dry cough, lung irritation, chest tightness, reduced exercise tolerance.  Levalbuterol inhaler sometimes helped, but not consistently.  After about a week, I saw my primary care physician (assuming it was seasonal allergies). I began taking Singulair. A few days later, I added Zyrtec, and had a chest x-ray.  Over the next few days I started to improve and was feeling better by 2 weeks post vaccination.  I received my second dose (Pfizer EU0120, left arm, same location) on 4/19/2021. The day after, I felt feverish and tired as expected and slept most of the day. On the 20th, the same respiratory symptoms as described above reappeared at their previous intensity. At the advice of my doctor, I am continuing the Singulair and Zyrtec, and monitoring symptoms. I have not yet recovered.  Note: I have no previous history of asthma
Pt recv vax & devel inj site rxn of redness,warmth. Described as "cellulitis".
Headache, different from what I normally get, feels like a vise on my head around temples.  Came on 5 days ago, 3 days after receiving vaccine, comes and goes, does not respond to any type of medication.
I just wanted to report what appears to be a minor delayed reaction to the Moderna vaccine. I received my first dose on Monday 1/18. I had only a sore arm and a minor headache for a day or two afterward. However, this Monday (day 7) I had what felt like a mosquito bite at or near the injection site and it itched quite badly that night. Yesterday (day 8) I didn?t notice much, but last night it started to itch again and I noticed that it had developed into more of a rash around the injection site (nowhere else). It was pink and somewhat warm. I put ice on it and took a Tylenol and it was much improved and it hasn?t bothered me much since then. It is calmer today, but still pink.  I am not really concerned about this, but I thought I should let you know just in case there is something else I should know or do. I plan to go ahead with my second dose which is scheduled for 2/15.
Pt developed tachycardia confirmed by her Smart Watch and Physician Assistant.  Her rate went up to 170s.  On June 17, 2021 she suffered a left thalamic infarct by MRI.  She continues have tachycardia usually in the rates of 120s
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
This case was reported by a consumer via call representative and described the occurrence of pain in arm in a 51-year-old female patient who received Influenza vaccine unspecified. In October 2015, the patient received Influenza vaccine unspecified. In October 2015, 1 day after receiving Influenza vaccine unspecified, the patient experienced pain in arm. In April 2016, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to Influenza vaccine unspecified. Additional details were provided as follows: This case was previously reported to a doctor. The patient reported that she experienced severe pain in left arm injected with an unknown GlaxoSmithKline flu vaccine last year. She reported that this pain had lasted 6 months after injection. The patient was required to visit the emergency room. The patient also reported that she had visited a specialist regarding the pain.
Pt received FLUZONE vaccine. She stated she had a fever, body aches and SOB. She took an ADVIL and called back 2 hours later that she feels better.
5 silver dollar size bruises appeared in various spots all over the body; This is a spontaneous report from a contactable consumer or other non HCP. This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 5 silver dollar size bruises appeared in various spots all over the body (contusion) 5-6 days past getting Covid vaccine on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported.  The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.
rashes on her arms and chest area; This is a spontaneous report from a contactable pharmacist. This pharmacist reported that a 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 11May2021 (age at vaccination:29-Year-old) as dose 1, single for COVID-19 immunisation. The patient 's medical condition and concomitant medications were not reported. On unspecified date in May2021, the patient experienced rashes on her arms and chest area. Patient was not allergic to shellfish. Want to know the plant source where the lipid was derived and if there is soy on the list of ingredients. All lipid excipients used in the vaccine are either from plant-derived sources or are synthetic and have no animal products. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd pneumococcal vax & p/vax lab eval revealed did not seroconvert for number 12 & 14 capsular antigen;