chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Dose Number:3; Chronic Spontaneous Urticaria (hives); Chronic Spontaneous Urticaria (hives); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:00 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZID; AMLODIPINE. Past drug history included: Ace inhibitors, reaction(s): "Allergies: Drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Chronic Spontaneous Urticaria (Hives)", "Chronic Spontaneous Urticaria (Hives)"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Oct2021 15:00, outcome "unknown", described as "Patient received Dose Number:3"; CHRONIC SPONTANEOUS URTICARIA (medically significant), URTICARIA (medically significant) all with onset 2021, outcome "not recovered" and all described as "Chronic Spontaneous Urticaria (hives)". The event "chronic spontaneous urticaria (hives)" and "chronic spontaneous urticaria (hives)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of chronic spontaneous urticaria, urticaria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient never had hives before the covid vaccine and was having hive outbreaks ever since the covid vaccine. The patient received Cortisone Shots (3 rounds) Pepcid and 4x antihistimes daily for the treatment of adverse event. Prior to vaccination, he patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received her second SHINGRIX vaccine on 11/26/18. The patient reported redness and swelling of the left face and bilateral leg pain. She took a pain reliever and an antihistamine after and reported decreased symptoms. Patient reported on 11/29/18 to pharmacy.
Marked swelling, redness at vaccine site with 12 discrete papular lesions anterior chest wall and base of neck. 1st observed and evaluated on Feb. 15, 2003.
9/22/04: Redness and edema from elbow to shoulder. Left deltoid: Recommended Tylenol , warm soaks and take to MD. 9/23/04: Talked with aunt who states she did not take child to MD and he was better today.
Had redness and welt at injection site. Unmediated and arm sore for week. Redness  and soreness leftwithin 5-6 Days. On day 8 injection site became red, raised, slightly warm and itching.
SHINGRIX was administered on 05-09-18. On 05/13/18 she noticed a rash on the right buttock, (R) leg, and right side of back. On 5/14/18 she saw a dermatologist who diagnosed shingles. Rx: VALTREX one gram TID for 7 days and LYRICA 50 mg TID for 10 days. Drying up on 5/18/18.
temp 10 days later x 3 days 105 given APAP/advil-wiped pt down;
Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in chest. Went to ER and received labs and EkG with nothing outstanding. Dizziness continued for a total of 3 hours on 4/9. 4/10 I felt a brain fog and vertigo feeling for most of the day. 4/11 I felt better. 4/12 I had another episode of feeling like I was going to pass out along with brain fog. I went to urgent care and got more labs drawn.
pt recvd vax 30JUN94 & 9JUL94 pt devel swollen glands under ears & base of the skull; No further details were provided;
8 days after receiving the Moderna vaccine, I noticed a large and swollen red area on my arm where I was injected. It is not painful or itchy, just warm to the touch. Over night, the area got less red and less warm but the swollen area had gotten larger.
Patient had a syncopal episode previously thought it was a possible seizure. EEG and CT brain were negative. Pt became febrile on 04/01/2021 (101.9 ).
pt. vax w/ 2nd dose of M-M-R II vac. 13SEP89 & on 19NOV90 was dx w/ mumps.
This spontaneous report as received from a pharmacist refers to a male patient of unkonwn age with no drug reactions or allergies. On approximately 30-JAN-2014 (reported as about a week ago), the patient was vaccinated with a dose of ZOSTAVAX (lot# J011339, expiry 13-DEC-2014), 0.65 ml once, subcutaneous. There were no concomitant medication and pertinent medical history. The pharmacist stated patient returned to pharmacy at an unspecified time recently with a prescription from an unspecified physician for a "MEDROL dose pack" for an unspecified ailment that developed at an unidentified recent time in 2014. The outcome of an unspecified ailment was unkonwn. Additional information has been requested.
Body/joint aches/pain, horrible headaches on a weekly basis, started having menstral cramps and heavy bleeding even though I have an IUD and haven?t had a period in years.
Patient awoke the next day with rash on arm in which GARDASIL given; Rash spread to abd with leg and gradually all over her body. Rash was slightly itchy and she took OTC Benadryl which helped. She states she felt feverish but did not check her temp. She had hoarse voice and complained of slightly sore throat; complained of GI puffiness and loose stools and migraine
Information has been received from a pharmacist concerning a 73 year old female with a history of hypertension who on 31-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 04-APR-2008, the patient experienced angina. It was unknown if the angina resolved. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild
tender arm but was still able to do her daily activities with no issues.; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tender arm but was still able to do her daily activities with no issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced tender arm (tenderness) but was still able to do her daily activities with no issues.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
palpitations after first dose made MUCH worse after second dose, heart rate issues, frequent PVCs noted in Holter monitor, chest pain, heart races after exercise (frighteningly so) The Problem has not been resolved yet, I?m still suffering.
Patient recevied COVID vaccine and while waiting in lobby became lethargic, clammy, discolored, and was unconcious for about 30 seconds Mother states first vaccine he did not get a reaction just was sleepy. Stated he had Leukemia and has been in remission for the last 10 years.
This spontaneous report as received from a medical assistant refers to a 10 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003138: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Pt came in 10/17/17 and reported redness that spread across her arm. She stated that soreness started 10/14/17 in the evening and Monday 10/16/17 was fire red and warm to touch. She stated she was seen at the allergist office and they wanted her to report possible incorrect injection site.
red rash; itchy and hurts at the same time; itchy and hurts at the same time; 2x4 inches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site). At the time of the report, RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Swelling on arm, swelling on left side of face and neck area.  Shortness of breath ,Dizziness, Weakness, Fatigue Swelling, weakness,  and dizziness happened within 2 hours of having the vaccine. The shortness of breath started not to long after. The fatigue started about 4 hours after.
This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Pt had a vagal response approximately 13 minutes after vaccination. Pt stated he was light headed, became pale, diaphoretic, bradycardic, then became extremely lethargic. Pt became difficult to rouse but never lost consciousness. Pt states he has a history of vagal response to needles of all types.
Fever 99.9, freezing cold, body aches, very sore left arm.  It started late night the day of my vaccine  and I took my temperature at 2:30 am when I was so cold. Taking ibuprofen which helps aches but not really helpful with fever yet.   I still have a fever now so it?s been at least 13-14 hours.   I went to work this morning but left after 3.5 hours because I was FREEZING.
2 or 3 days after vaccination noticed itching. Noticed patches of red on upper thigh and arms and trunk and small red bumps like whelps. He put A&D ointment.
Fever 102.7  Diarrhea  Achy body  For one day
First diagnosed with pneumonia 02/23/2021 (multiple times); hospitalized with low oxygenation/high pulse 04/12-14/2021, started 24/7 oxygen; 05/04/2021 anesthesiologist asked what was wrong with lungs when awaiting transport to surgery for back operation; 05/26/2021 Pulmonologist diagnosed interstitial lung disease - stating likely never pneumonia - started Prednisone 40 mg, one month o July 21, 2021, then 20 mg, one month, dropped to 10 mg for one week. So weak pulmonologist restarted 20 mg along with Micophenolate.  Around August 31, 2021 declined in energy and stamina till barely can get to bathroom by self. Continuing through current.
11-19-14 Mother called and stated child had a "knot" on leg where Dtap was given. On 11-20-114 Mother called and stated the area where Dtap was given had grown to the size of a "softball" and was purple. Child was not eating and had a temp of 99.0F. Instructed mother to take child to a doctor which she did. The child was diagnosed with a staph infection at site and put on antibiotics.
Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu),  muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic  (Cefdinir, just in case) and steroid shot.
Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness(  any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move.  These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.
mom states pt started w/fever to 101, crying, screaming on days p/vax; crying non-stop for 2-3 hrs @ a time, unconsolable; fever inc p/APAP wore off went to ER 10APR93; tests neg; pt still fussy;
Tachypnea, HYPERtension & Tachycardia Employee endorsed initial "lightheadedness and flushing" and mild difficulty breathing. Patient was hypertensive With BP Sys in 160s-170s and Dys 90s, Patient denies history of hypertension Patient was also experiencing tachycardia with HR ranging from the 90s- 110s. Patient reports "Heart beating really fast", and "heart beating out of chest" Patient was transferred to ER at 1330 for further evaluation.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced headache and fatigue. Patient's blood pressure reading 1 minute post vaccine administration was 124/70, HR-78, O2 100%. Extended time period in Observation area. Repeat blood pressure 15 minutes post vaccine: 134/84, P 78, O2 99%. Patient reported no worsening of symptoms. Bottled water and crackers given to patient. Family present for duration. 30 minutes post vaccine, BP 139/89, P 80, O2 100%.
Groggy; Energy decreased/Low energy; Intestinal inflammation/Inflammation in intestines; Ache/Achy; Nausea; Crohn's aggravated/Crohn's flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups), SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines) and PAIN (Ache/Achy) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product (HUMIRA) for Crohn's disease.    Patient had no known allergies and no other relevant medical history.  Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2022, the patient experienced CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups). On an unknown date, the patient experienced SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea). At the time of the report, CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups) had not resolved and SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient underwent colonoscopy and results were not provided.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira The reporter's causality for the event(s) of Crohn's flare ups, groggy, low energy, inflammation in intestines, achy and nausea was not provided.
shaking with chills; dizziness; weakness; had a hard time starting; fever of 100.3f; slight headache; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting/feeling abnormal.  The patient's medical history was not provided.  relevant concomitant products usage were not reported by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) fever of 100.3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting.  Treatment details not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever of 100, 3f, shaking with chills, slight headache, dizziness, weakness, had a hard time starting was unknown.
Bilateral bruising on hip and thigh; This case was reported by a physician via sales rep and described the occurrence of contusion of thigh in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced contusion of thigh. On an unknown date, the outcome of the contusion of thigh was recovering/resolving.   It was unknown if the reporter considered the contusion of thigh to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced bilateral bruising on hip and thigh, starting to went away at time of follow up visit 2 to 3 days following vaccination. The reporter consented to follow-up.
Patient received PNEUMOVAX 23 in his right arm and FLUZONE High Dose in his left arm. He went home and a few hours after receiving PNEUMOVAX 23 in his right deltoid, experienced severe pain when raising his right arm. He took a "scalding hot" shower and took 3 ibuprofen. At 7:30pm, he called the pharmacy back and stated he was feeling a little better after the ibuprofen but this was unlike any pain he has felt before. He stated it was not soreness, but pain when raising his arm. He does not feel pain when pushing with his arm, only raising it. He stated it is not red, hot, or swollen. He stated he will try an Epsom salt bath, massage, and ice.
Information has been received from a physician concerning her daughter, a 20 year old female with a family history of leave in migraine and multiple sclerosis who on an unknown dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). Shortly, after receiving the second dose, the patient developed a severe headache and a significant pain at the injection site. Prompting a trip to the emergency room and a computerized axial tomography scan of the brain were taken. She was given a diagnosis of migraine. The headache resolved in approximately 24 hours on pain medication. There were no other complaints than significant pain at injection site. Additional information is not expected.
Information has been received from a registered nurse concerning a 22 year old female with pertinent medical history or drug allergies/reactions who on 7-JAN-2009 was vaccinated IM with the first dose of GARDASIL and on 9-MAR-2009 was vaccinated IM with the second dose of GARDASIL (lot # : 661703/0651X). There was no concomitant medication. In March 2009, after receiving the second dose, the patient experienced injection site reaction. The patient complained of "puffy arm with redness, itching and burning". At the time of this report , the patient was recovering. The patient called the office for medical attention. Additional information has been requested