chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme hyperactivity and alertness; Extreme hyperactivity and alertness; Heart rate is exacerbated; Arm is sore at the injection site; Neck muscles tight; enthusiastic/ the alertness and energy is concerning; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included alpha-gal, attention deficit-hyperactivity disorder, allergy to grains (barley) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. On 28Feb2021, the patient underwent BinaxNow SARS-CoV-2 test (Test type: Nasal swab) and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA) of dose 54 mg q.d and 18 mg qd and bupro (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 11Mar2021 at 09:00, 7 hours post vaccination the patient experienced extreme hyperactivity and alertness, even after having consumed 20 oz of red wine (Pinot noir) to try to sleep, the patient was amazingly alert and enthusiastic. Heart rate exacerbated. The patient reported that it felt like she overdosed on ADHD medication (she did not- took all her medication at 06:30 AM EST). The arm was sore at the injection site and neck muscles tight, but the alertness and energy was concerning 7 hours later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme hyperactivity and alertness, was amazingly alert and enthusiastic, heart rate exacerbated, arm sore at the injection site and neck muscles tight was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
difficulty in swallowing; dry throat is still there; Dry mouth; massive hives; 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 18 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Jan2022 01:00 (Lot number: FK9896) at the age of 18 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel syndrome. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1), for COVID-19 Immunization; Comirnaty (Dose 2), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 30Jan2022 02:00, outcome "not recovered", described as "massive hives"; DYSPHAGIA (non-serious) with onset 31Jan2022, outcome "recovering", described as "difficulty in swallowing"; DRY THROAT (non-serious) with onset 31Jan2022, outcome "not recovered", described as "dry throat is still there"; DRY MOUTH (non-serious) with onset 31Jan2022, outcome "not recovered", described as "Dry mouth". The events "massive hives", "difficulty in swallowing", "dry throat is still there" and "dry mouth" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria, dysphagia, dry throat, dry mouth.  Additional information: Caller was an 18-year old female who received the 1st, 2nd, and booster dose of Comirnaty. Caller said she was fine with the 1st 2 doses however, with the booster, she had massive hives and experienced difficulty in swallowing. Caller gave lot number FK9896 and wanted to know if this has any relation to the adverse effects she had. Caller added she just called in to report this. The caller is calling about the Pfizer booster, the third dose of the Pfizer covid vaccine. The caller wants to report a side effect she experienced. The caller received all 3 doses by Pfizer and was fine with the first two doses. With the third dose the caller had massive hives and difficulty swallowing, but no chest pain or problems breathing. Has the same lot had other complications. 1 hour after the caller received the vaccine the hives started, at 2:00. The caller is on steroids and other medications and has been to 2 emergency departments. The caller was never admitted as a patient because it got better with the stuff she was taking but now it keeps coming back. The difficulty swallowing is getting better but the dry throat is still there.  No follow-up attempts are possible. No further information is expected.
6/22/12 - noticed 2 small clear vesicles on (L) wrist - continued to have several more over next 2 weeks. 7/7/12 developed fever, swollen lymph nodes. No fever today. Note: also had MMR on 6/22/12.
Patient given 11 y.o vaccines at well check. Approx 8-9 min after vaccinations of Tdap, HPV, MCV-pt developed hives on Left cheeks only and complained of abdominal discomfort. NO resp distress or vomiting. nml vital signs. Pt given a cup of water which resolved abd pain. Given 25mg of Benadryl-approx 5 min post benadryl minimal resolving of uritcaria. no new sites of Urticaria. Pt was observed for another 30 min. normal vitals and was able to ambulate normally out of office with no new symptoms nor worsening of urticaria.  Mother reports that on 8/11/17 evening Pt developed hives on left arm which resolved after benadryl. no reports of any other symptoms.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with ROTATEQ oral liquid (lot #: M031651 with expiration date: 30-MAR-2018 and lot# M004542 with expiration date 18-OCT-2017) (dose, strength and frequency were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013304: US-009507513-1703USA013305.
I had NO adverse reaction to this Covid vaccination. I just thought you might want to know how a person who is considered immunosuppressed reacted to the 4th dose (1st booster) after 3 Primary shots. My arm wasn;t even as sore with this shot as it was with the 3rd Primary.
A few after hours after second dose, I have experienced vomiting, diarrhea, chills, sweating, feeling faint/weak. Still 2 days later still having same side effects
Information has been received from an unspecified reporter referring to a 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
sinuses shut down; This is a spontaneous report from a contactable consumer reported for a patient (Reporter's wife).   A female patient of unknown age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on 08Feb2021 11:00 AM for COVID-19 immunization. Medical history and concomitant medications were not reported. On unknown date the patient experienced sinuses shut down. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt recvd vax & 3 hrs p/exp chest discomfort & tightness; these sx resolved in 2 days;
Patient has (L) arm pain from upper arm to the shoulder and around to the back of the arm. She is having limited ROM of the shoulder due to discomfort. There is a pulling sensation when she reaches up and forward or backwards. Onset is immediately follow receiving 3 vaccinations at her CPE 11/2018. Patient referred to ortho to rule out underlying shoulder disorder and impingement.
Muscle cramps, legs, thighs and hands; This case was reported by a consumer via call center representative and described the occurrence of muscle cramp in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was not recovered/not resolved.   It was unknown if the reporter considered the muscle cramp to be related to Shingrix.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter comment: The patient self-reported this case. The patient received the first dose of Shingrix a few days ago. The patient reported that about 5 hours after the dose, the patient experienced muscle cramps in the back of legs and thighs, and also cramps in hands. The patient reported that symptoms had not yet resolved.  The reporter consent to follow up.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/4-9/10.
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
Patient had had poison ivy dermatitis diagnosed 7/19 and treated with prednisone taper. Rash was improving. 7/28 she received her vaccine, and the next day her poison ivy rash dramatically worsened.
After vaccine administration patient was waiting in observation area and started to feel dizzy and nauseous.  Pharmacist checked patient's blood pressure (which was high 168/98) she takes amlodipine 5mg for high blood pressure.  Patient had already taken her amlodipine earlier that morning
323PM mom reports rt arm swollen, will not move arm & crying in pain; given APAP & cold compress;
Immediately after vaccination patient had a bruise at injection site and swelling at injection site. She was told to watch the injection site and call the pharmacy that night to let us know of any further reactions. On 11/2/16 she called to describe a bruise at the injection site and red, hot blotches down her arm and elbow that started that morning (morning after the injection). There was no pain. There was itching at the injection site. On Thursday 11/3/16 she was called to check on the reaction and she stated that it was getting better and not getting worse.
PUI onset of symptoms was 7/24/21 she had all symptoms and went into the hospital 8/3/21 she had covid pneumonia and has a blood clot in her right leg and several in each lung.
Crystallia sudamina rash developed on body trunk and upper extremities 30 min after administration. Vaccine is Trimovax of Sanofi Pasteur Lot No shown below.
received Moderna on 4/14/21, received 2nd dose of Pfizer on 5/3/21, denies any symptoms, pt. left site.
CKMB enzymes and Myoglobin levels very high (14.5 and 113 on 1/24/22. Started with probable cytokine storm (causing extreme muscle pain and some chest pain) on 1/21/22, which happened a few more times in the next few days. No outward Covid symptoms other than fatigue for a day. Covid test was not done until the 30th at a 3rd ER visit and came back positive. Repeat testing for CKMB and myoglobin has been done since getting over it and there is a very slight decrease, but the levels are still critical (CKMB IS 11.5, Myoglobin 86) as of 2/11/22. Going to see a cardiologist on 2/17/22 for consult to assess if there is permanent heart muscle damage.
Had a panic attack (shortness of breath, confusion) 20 minutes after administration of meds. No hives on swelling noted.
Suspected vaccination failure; Shingles; nerve feeling/pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it in April).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and nerve pain (Verbatim: nerve feeling/pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and nerve pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 The case was received from the patient interactive digital media. The patient was vaccinated and 3 months later he/she had on left leg on the back of it where he/she had the shingles. The patient stated that he/she still had not recovered all the nerve feeling on half of his/her foot and the pain was unbelievable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Three days after the vaccine, I lost my voice and have yet to recover it and it has been over a month.
Patient presented to the ED with full body rash beginning 5 days post receiving zostavax/influenza immunizations. The rash began on back and progressively over all four extremities and abdomen. The rash consists of vesicles on erythematous base in various stages of resolution. Rash is not in dermatomal distribution. The rash is pruritic and not painful. Has been scratching at them causing them to break open and scab. Patient admits to night sweats for the past week, difficulty urinating, nausea, vomiting, generalized weakness, and SOB. Also admits to episode of non bloody diarrhea 2 days ago, and loss of appetite for the past 3 days. Patient denies dysuria, abdominal pain, fever, and chest pain.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that since April 2014 VAQTA (lot#, dose, route not reported, strength reported as 25/0.5, unit not reported) was improperly stored and on an unknown date in approximately 2014 the patient was vaccinated with VAQTA. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. The outcome of is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA004354 and 1410USA004355). Additional information has been requested.
I tested positive for COVID-19. I had a fever between 100 to 101 and a headache for a couple days. I also had fatigue and a cough. I talked to the nurse on the phone and asked her if I should be prescribed PAXLOVID and they did not recommend it for me.
Extreme itching on scalp. This is not due to dry skin or dermatitis. I have changed all shampoo and soap products to make sure. It is unrelenting and constant.  I have a 3" diameter circular rash centered on my spine half way down my back. This itches constantly also. I have changed all detergents and use extra rinsing to make sure it is not from clothes or contact. Again, this is not "dry skin" or seasonal allergies. It has been non-stop since it started.  This is ongoing.
Headache, Myalgia, Diarrhea, Fatigue/ Chills Narrative:
Information has been received from a nurse concerning a 60-year-old patient who on 18-NOV-2008 was vaccinated with a dose of 0.5 ml PNEUMOVAX (lot #, route and injection site unknown). Concomitant vaccination also included injection of influenza virus vaccine (unspecified) in separate arm. ON 19-NOV-2008 the patient experienced an abnormally swollen arm at injection site over the entire arm. It was unknown if the patient sought any medical attention. The patient's outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 LEFT OLECRANON FX, W INTRAARTICULAR EXTENSION DISPL ROUT SUBSEQ J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 RIGHT PROXIMAL HUMERUS UNSPECIFIED TYPE FX, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT
rash and low grade fever onset 9 days after vaccine administration, looks like measles vaccine related rash
Information has been received from a female patient of unknown age concerning herself. There were no current or historical conditions reported. On an unknown date the patient was vaccinated with ZOSTAVAX. There were no concomitant medications reported. In approximately FEB-2015, "a little over a week ago" the patient woke up with a rash on her leg from her knee up to her hip. She visited her physician and the shingles was confirmed. The outcome of shingles was unknown. The patient requested a refund for medical costs and the pain and suffering. Additional information has been requested.
This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M007728 (also reported as "M002778"), expiration date 21-MAR-2018, intramuscularly (exact dose and dose number were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported.  Additional information has been requested.
Mom called, and reported that the child has a few bumps around site and a knot the size of a quarter.
The evening of 6/23/04 the right arm was slightly swollen around injection site. By morning of 6/24/04, the right arm was red and swollen from shoulder to 2 inches above elbow. No fever. Complained of itchy arm. Suggest cool compress and refer to PMD for relief of pruritus.
One week after the injection, I began having arm pain again.  I looked at my arm and had a red bump under the injection site that was hot to the touch.  It was also very itchy.  I emailed my doctor and she advised to use a cold compress and ibuprofen.  I also texted my boss (most of the dispatchers in my center received our vaccine's that week) and asked if she had heard of anything similar happening to ther dispatchers.  She had the same bump and said it went away the next day and was just a large red area now.  It grew pretty large, taking up a lot of my outer arm area.  I put cold compress and the lump went down but I looked like I had a large sunburn that was itchy and I also had arm pain.  On Sunday, at work, I started looking online for other people having the same reaction.  I found an article where a healthcare worker had what she described as an allergic reaction one week after receiving her first dose.  I realized it was probably an allergic reaction and took benadryl that night and the next night and it was gone.  At least 5 or 6 other people I know had the same reaction, one person had it worse.  I advised them to fill out this form.
Red pruritic round macular rash, approx 4cm in diameter, around vaccine injection site that appeared 7d after vaccine administration.
Pt. fainted a few minutes after receiving vaccine. Lost 2 teeth. Felt nauseous. Went to ER. Released from ER same day.
soreness in her arm/Pain top part of thighs; pain in the lower abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:15 (Lot number: EN6199) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2016 (ongoing); "High Blood pressure", start date: 2000 (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2016 (ongoing); DILTIAZEM HCL taken for hypertension, start date: 2000 (ongoing); OLMESARTAN taken for hypertension, start date: 2017 (ongoing). The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 11Mar2021, outcome "not recovered", described as "pain in the lower abdomen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in her arm/Pain top part of thighs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain lower.  Additional information: Patient did not received any other Pfizer vaccine on the same date of BNt162b2 administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 1 week ago, she had her shot and she experienced soreness in her arm but on Thursday (11Mar2021) she began having pain in her lower abdomen and it had continued to hurt. She asked if this was a complaint that anyone else was giving. She can barely get up. She didn't have this pain until she had the vaccine. She thought that the pain would go away. When she laid down, the pain got bad. Last night the pain was horrific. She took Ibuprofen and it took the edge off. The pain does not go completely away. The pain was worse when she laid on her sides. It was driving her nuts. Taking Ibuprofen helped her to be able to do things. The pain was in the lower abdomen and top part of thighs. She has not seen her physician for this. She had a previously scheduled appointment with her cardiologist and had an Echo and EKG. Events did not result to physician office and emergency room visit.   No follow-up attempts are possible. No further information is expected.
Covid-19; felt a little sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) and MALAISE (felt a little sick) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19) and MALAISE (felt a little sick). At the time of the report, COVID-19 (Covid-19) and MALAISE (felt a little sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Concomitant medications of Antihypertensives. It was reported that the patient was extremely healthy. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the Moderna Covid-19 vaccine for his Primary Series and booster shots. The patient received his flu shot around the same time as his Moderna Covid-19 booster shot. Treatment information was not provided.   This case was linked to MOD-2023-710668 (Patient Link).