chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in my ear; anatomical location and route of administration, consumer stated, "It was the left shoulder."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Joint pain" (unspecified if ongoing), notes: Joint pain. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, LOT#: ER2613., ), administration date: 16Mar2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "ringing in his ears", "increasingly harder for him to hear"; BNT162b2 (Bivalent BioNTech (Suspect captured as Pfizer BioNTech Covid-19 Vaccine Bivalent) , LOT#: EW0150), administration date: 09Apr2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "anatomical location and route of administration, consumer stated, "It was the left shoulder."", "Joint Pain". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 10Dec2021, outcome "unknown", described as "anatomical location and route of administration, consumer stated, "It was the left shoulder.""; TINNITUS (non-serious), outcome "not recovered", described as "ringing in my ear".  Additional information: The patient informed that he received the Vaccine 2 and guess that was couple of years ago, when it first came out. He got the Booster, got the 2 shots and a Booster, and he had a constant, ringing in his ear, non-stop (conclusion that is Tinnitus).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139633 same reporter/patient/product, different dose/event in time;US-PFIZER INC-202300133258 same reporter/patient/product, different dose/events;
Received the second Pfizer vaccine on a Wed. Expected reactions started Wed .night,  fever of 101, muscle aches, fatigue, headache. Same expected symptoms on Thursday. Feeling better on Friday  but noticed an unusual feeling in my chest. Checked my pulse and I was skipping beats. Went to the cardiologist. Wore a Halter monitor for one week. Showed  super ventricular ectopy.  Palpitations. Not a problem for me per my doctor. This side effect may be coincidental but since it happened after the second Pfizer vaccine and it is not a listed side effect on the CDC website, my doctor and I decided to report it.
Mom called stated pt ran t104.5 last noc; c/o lt arm being sore, red area under inject site; c/o pain in both arms; suggest warm compress & APAP take pt to MD r/o poss sterile abscess; mom stated pt had twitching this last episode;
Swelling to twice the size of my arm for 4 days. Swelling started to dissipate after 4 days but still there.   Extreme pain. Red, fevered arm.  this, after taking a benedryl, 25 mg first night. Also had severe chills first night. this was 2nd pneumomonia shot.  Firt one, in 1999 had no reaction.
This case was reported by a consumer and described the occurrence of arm twitching in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included 1st and 2nd doses of TWINRIX (GlaxoSmithKline) given in April 2009 and May 2009, both in the left arm. There were no concurrent medications. In October 2009 the subject received 3rd dose of TWINRIX (unknown, left arm). On 8 December 2009, approximately 2 months after vaccination with TWINRIX, the subject experienced arm twitching in his upper left arm. The twitch was reported to be involuntary and not painful, occurring about 3 to 4 times a day, mostly in the evening. At the time of reporting the event was unresolved.
Few hours after I got the vaccine I experienced sinus pressure in my left nostril. I went to blow my nose and a blood clot came out. I tried to blow my nose again but nothing came out. I went to sleep and the next day (the day after I got the vaccine) I still felt the same sinus pressure. I showered about mid-afternoon that day and after I got out of the shower my nose was bleeding, but it was a mild nose bleed. The rest of the day, I experienced a headache that felt like it was coming from the place I experienced the sinus pressure. The head got progressively worse as the day went on, I took Advil to get rid of the pain and went to sleep early. The next few days I experienced a headache that would be mild when I woke up in the morning, then got progressively worse as the day went on. Right now (4 days after the vaccine as I'm submitting this report) the pain of the headache has somewhat subsided, but the pain is still present.
The day after the injection, pt's arm turned black and blue from shoulder to elbow. Cold compress. Pt refused to see Dr. Condition resolved on its own.
Nausea and headache (2 days) Fever of 100*  (2 days) Arm pain  (5 days)
This spontaneous report was received from a medical assistant, concerning a 17 month old male patient with no pertinent medical history of drug reactions/allergies. On 11-SEP-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose number was not reported), 0.5 ml, lot number and expiration date reported as K004540 03-DEC-2016, intramuscular route for immunization. Other suspect therapies included PREVNAR 13. Medical assistant reported that patient was taken to emergency room (ER) (name and location unspecified) on unspecified date for injection site reaction but patient was not admitted. Patient was brought in to office on 17-SEP-2014 (reported as today) and was diagnosed with cellulitis around injection site. Medical assistant also reported that there was a small knot around injection site. At the time of report the outcome was reported as recovering. Patient sought medical attention at the ER and office visit. Patient received ROCEPHIN and unspecified oral antibiotic from the ER. Additional information has been requested.
Information has been received from a health professional concerning an 8 year old Hispanic male student who in 2000 (previously reported as approximately May 2004) was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 30-APR-2007 (previously reported as May 2007), the patient developed a mild case of chicken pox characterized by blisters, fever, and rash all over the body. Medical attention was sought on that same day when the patient went to the physician's office. In May 2007 the patient recovered. No product quality complaint reported. Additional information is not expected.
Fever symptoms, aching, cold sweat, uncontrollable shivering in warm clothes/room. Headache.   Morning after vaccine: nausea, dizziness, fainting
03/20: Infected (anti-biotics); 03/21: Pain/Loss of movement (physical therapy, cortozone shot anti-inflammatory meds).
Patient developed painful upper arm in the deltoid area secondary to vaccine. She also complained of weakness, soreness of the legs, generalized malaise and muscle aches. She was offered Tylenol.
7/24 woke up with rash on legs and abdomen. Only had a few areas, but each day thereafter increased. On 7/26 felt hot but did not take temp. On 7/30 rash was on face to face looked puffy. Went to ER 7/30. They said could be vaccine or something else and gave po Benadryl. In clinic 7/31, not reported better. 7/31 still had red raised whelps on body to face.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Additional Details: Patient lost conciousness while waiting his 15 minutes after recieving his first Pfizer COVID-19 vaccine. We ran to his aid, and upon arriving at his side we laid him down on the ground. Before we were able to assess his pulse and breathing status he jolted awake and started shaking his arms and kicking his legs. After a few seconds of panic the shaking stopped and he sat upright. EMTs arrived on scene and confirmed his BP and pulse were returning to normal.
Pt reported terrible shoulder pain 2 days after receiving 3rd dose; Loss of range of motion; Vaccine was administered in the left leg; Dose received: 3; This is a spontaneous report from a contactable reporter (pharmacist).   A 28-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left leg, administration date 16Dec2021 at 09:45 (Lot number: FD0809) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was reported as unknown. Concomitant medications were not reported. Other vaccinations included: FLUCELVAX taken for Immunisation, start date: 09Dec2021, stop date: 09Dec2021. Vaccination history included: Covid 19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), and Covid 19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), administration date: 24Apr2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 16Dec2021 at 09:45, outcome "unknown", described as "Vaccine was administered in the left leg"; IMMUNISATION (non-serious) with onset 16Dec2021 at 09:45, outcome "unknown", described as "Dose received: 3"; ARTHRALGIA (non-serious) with onset 18Dec2021, outcome "unknown", described as "Pt reported terrible shoulder pain 2 days after receiving 3rd dose"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 18Dec2021, outcome "unknown", described as "Loss of range of motion". It was unknown whether therapeutic measures were taken as a result of the events arthralgia and joint range of motion decreased.  Additional information: The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Systemic: Abdominal Pain-Medium, Systemic: Bell's Palsy-Medium, Systemic: Nausea-Severe
On 9/30/10 he developed a mild rash on his stomach, near the top of his diaper.  On 10/30/10 the rash became more prounounced (more red, bumps became more raised), his cheeks were flushed, and his temperature was 104.9 when checked with a temporal artery thermometer.  We gave him a dose of oral Tylenol (infant's Tylenol, 1.2 ml) and his temperature decreased to 99.4 within 30 minutes.  He acted sick for approximately 24 hours (tired, decreased appetite, poor sleep), and appears to be feeling better now.
Headache started about 5-6 hours after injection, intensity increased throughout the next 14-16 hours. Generalized achy muscles lasted for 24 hours. 3 days after injection, skin peeling noted around finger nails and under nailbed.
Patient reported adverse reaction 11/6/23: patient reported fever/chills onset 10/24/23 approximately 10:30 PM. Patient denied taking ibuprofen or acetaminophen. Patient went to emergency room 10/24/23, received IV fluids, discharged 10/25/23.
Dizziness - hx of high blood pressure.  States she gets white coat syntrome.  Checked blood pressure 190/90;  P 82.  Had a snack and juice and observed.  Discharged at  9:47  B/P 188/80  P 74.  Dizziness resolved.
sore arm for 6 months; after doses had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (after doses had fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (has a bad immune system because of this). Concomitant products included ZINC, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), VITAMIN D [VITAMIN D NOS], ETANERCEPT (ENBREL), VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], FLUOXETINE HYDROCHLORIDE (PROZAC) and PREDNISONE for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (after doses had fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (after doses had fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported after both doses, had fatigue and sore arm for 6 months.   Patient did not take any treatment.   This case was linked to MOD-2021-406307 (Patient Link).
The neuropathy on his feet also intensified up his legs; The photophobia was so bad/ it got worse with the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: May2021) at the age of 69 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Pfizer, Lot: EL9262, Time given: Believes something like mid day early afternoon, Dose given: Unknown; Asking what were the choices?, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Photophobia".  The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "The neuropathy on his feet also intensified up his legs"; PHOTOPHOBIA (non-serious) with onset 2021, outcome "not recovered", described as "The photophobia was so bad/ it got worse with the second vaccine". The events "the neuropathy on his feet also intensified up his legs" and "the photophobia was so bad/ it got worse with the second vaccine" required physician office visit.  Clinical course: Patient received his 1st dose of the vaccine on 21Jan2021 and developed photophobia shortly after receiving the vaccine as patient was not able to look at his computer without getting a headache. Patient received his 2nd Pfizer COVID-19 vaccine on 11Feb2021 and the photophobia was so bad that he could no longer look at his cellphone or TV without getting a headache and also had some trouble with sunlight when outdoors. After 2nd vaccine, the neuropathy on his feet also intensified up his legs. Prior Vaccinations(within 4 weeks) reported as no.   Follow-up attempts are completed. No further information is expected.
Received zoster vaccine 7/9/08 SQ LA. States developed redness at site along with induration and pain to light palpitation. Palpation of indurated area measures 5"x5" states ice paks and OTC analgesia minimally helpful
Large area (> 20cm) of erythema and induration, warmth. Very pruritic, not tender. Afebrile. Lasted > 6 days.
The day after the shot I had chills, fever, lack of appetite, could not get out of bed. On July 21st I had pain under my underarm where the shot was taken. On Monday July 26th I started getting blotches like bruises on my legs and feet and on Friday July 30th the huge blotches became painful and I had to go to the hospital. I waited 9 hours for them to provide me advil. My legs and ankles swelled up and the blotches started to spread up my legs. I could not walk from Friday July 30th until Thursday August 6th after seeing a specialist who prescribed me Prednisone. The doctor at the hospital thought it was from strep but my tests came back negative for that. The specialist said it was either from a medication I took or a freak thing. I do not take medication. The blotches were painful, I could not put socks or shoes on, it was painful to touch my legs.
02aug90 pt vax 3rd hepta B. pt devel general body aches, fatigue, abdo cramps, and diarrhea.
long covid; diarrhea for almost a year/long covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "long covid"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "diarrhea for almost a year/long covid".  Additional information: Her friend (Name withheld) that she works with, has had diarrhea for almost a year and was told that she has long covid.She just wants to know if there is a product that can alleviate the symptoms, or is it just pushing the vaccine. Verified that all patients received the Pfizer Covid 19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After she received iz's, she was very quiet and then she seemed to stiffen and get tense, eyes stared off and she started to shake.
By the time I got home from Dr. office I had no sense of smell or taste. Ears became stopped up.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent condition or medical history was unknown. On an unknown date the patient was inadvertently vaccinated with a dose of improperly stored reconstituted M-M-R II (lot # M008589 with expiration date 16-FEB-2018 or lot # reported as M042846 with expiration date 21-OCT-2018, dose and route unknown) and diluent (lot # M013638 with expiration date 19-NOV-2018, lot # L039101 with expiration date 09-MAY-2018, lot # M045716 with expiration date 26-MAY-2019 or lot # M029027 with expiration date 14-MAR-2019) for prophylaxis. No adverse event was reported. The vaccine and diluent were stored under 62.4 degree Fahrenheit  for 5 hours and 30 minutes and 50.5 degree Fahrenheit  for 15 minutes. No data logger was involved.
Information has been received from a health professional concerning a 5 year old female pt who was vaccinated on 02/01/2000 with a dose of varicella virus vaccine, live. Subsequently, on approximately 02/11/2004, the pt developed breakthrough chicken pox with less than 50 lesions. Follow up information indicated that there was no single report of adverse reaction following varicella vaccination. The reporter  indicated that 49 other pt's developed breakthrough cases of chicken pox (WAES # 0405USA02615, 0405USA00572, 0405USA00593, 0404USA00575, 0404USA00576, 0404USA00577, 0404USA00578, 0404USA00579, 0404USA00580,  0404USA00581,  0404USA00582,  0404USA00583,  0404USA00584,  0404USA00585,  0404USA00586,  0404USA00587,  0404USA00588,  0404USA00589,  0404USA00590, 0404USA00591, 0404USA00592, 0404USA00593, 0404USA00594, 0404USA00595, 0404USA00596, 0404USA00597, 0404USA00598, 0404USA00599, 0405USA005600, 0405USA005601, 0405USA005602, 0405USA005603, 0405USA005604, 0405USA005605, 0405USA005606, 0405USA005607, 0405USA005608, 0405USA005609, 0405USA005610, 0405USA005611, 0405USA005612, 0405USA005613, 0405USA005614, 0405USA005615, 0405USA005616, 0405USA005617, 0405USA005618, and 0405USA005619). No additonal information is expected.
lt lateral deltoid area-warm, erythematous weil-20mm x 15mm; pain @ site per pt; no resp difficulty noted; Epi given;
Initial unsolicited report received from a non-health care professional (Patient's husband) on 15 September 2016. This case involves an 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose not reported) on 14 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported and illness at time of vaccination was reported as none. Concomitant medications were not provided. On 14 Sep 2016, same day following the vaccination, the patient experienced hives on face. On 15 Sep 2016, one day following the vaccination, the patient experienced itchy hives. It was also reported that, the patient did not had a previous reaction to flu vaccines. Lab data was not reported. Corrective treatment includes Allegra. Patient event outcome was reported as unknown. List of documents held by sender: none.
Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. Dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022.
I started to experience full body itches about 3-4 days after getting the first shot of the Pfizer vaccine. It would not be constant, but randomly throughout the day I would experience itching all over, mostly on firearms, back and legs, but nearly every part of my body would experience it at some point. This last for about 4 days the first time and seemed to disappear. After receiving my second dose of the Pfizer vaccine, the itching returned about the same timeframe after, about 3-4 days, but has not stopped yet. It has been about 3 weeks and I still experience the full body (debilitating at times) itches every day. I seem to experience mostly at night, although it does creep up during the day occasionally. I have not seen a doctor yet as I haven't felt the need to, but if it does continue, I might need to  because it it very distracting and uncomfortable at times. The itching is sometimes accompanied by very small, almost unnoticeable white bumps, but not always. I have mostly noticed these bumps on my forearms where there is less body hair.  On days where it is really bad, lotion sometimes soothes it temporarily.
On evening after vaccines both became red and itching.  Seen in office today and both upper arms on the outer aspect was red. Pt was seen by provider and given Atarax.
Pfizer-BioNTech COVID-19 Vaccine EUA: hospitalized due to failure to thrive after a hospitalization for acute hypoxemic respiratory failure due to COVID-19 pneumonia. Received remdesivir, steroids, supplemental oxygen, and anticoagulation. Discharged to home medically stable.