chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on her arm; Rash; 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 female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Jan2022, outcome "not recovered", described as "hives on her arm"; RASH (non-serious) with onset Jan2022, outcome "not recovered", described as "Rash".  Additional information: Patient had her first dose of the Pfizer COVID on the 13Jan2022. Patient had no reactions at all. Patient had a small patch of hives the following week on her arm. It was all cleared up. Patient hasn't had hives before. A friend of hers had a necklace which made her neck break out. Her friend gave her the necklace. Patient got the necklace last weekend. She put it on, and now she has hives. Patient never had a reaction to Nickle, but she had a rash on her neck that has been there since Monday. That has been five days since it has started. She knows for sure she got it at (Institute Name withheld). She knows that hives were a possibility. Is it okay to get her second vaccine on 03Feb2022. Patient wants to know if she needs to wait until the hives disappear in order to receive the second dose of the vaccine or be vaccinated while having the hives on her arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
numbing of entire left side of face: started at left upper lip, continued up left cheek to left brow,   This started about 20 minutes after receiving the shot.  It felt like I had received Novacaine.  I took Benadryl immediately upon returning home.  The numbness diminished but at this time---14 hrs later, there is still a numbness in the cheek and upper lip area--not as severe as previously mentioned.
States a rash appeared on left side of face and neck 2 days after shot given in right arm. She has a doctors appointment (routine) tomorrow and I told her to inform him of the rash.
Received shot high on arm. Has pain in left arm and has difficulty in moving arm without pain. Has been to neurologist and had physical therapy for past 3 weeks. Slight improvement.
103.9 fever; Muscle pain; Joint pain; Swollen lymph node in armpit; Stomach pain; Swollen lymph node in armpit that issharp pain and tender; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 12:00(at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and ethinylestradiol; norgestimate  (ESTARYLLA) on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified other vaccine within four weeks prior to the vaccination. On 02Apr2021 at 22:00, the patient experienced 103.9 fever, muscle pain, joint pain, swollen lymph node in armpit that is sharp pain and tender and stomach pain. The patient did not receive any treatment for the events. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 02Apr2021 at 22:00, the patient underwent lab test procedures which included body temperature and the result was 103.9 (unspecified units). The clinical outcome of the events 103.9 fever, muscle pain, joint pain, swollen lymph node in armpit that is sharp pain and tender and stomach pain was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2-2 1/2hr p/vax lost consciousness;uncontrolled shaking (sz).Hospitalized & dxed w/ new onset seizures.
Pustule on left side of back and swollen lymph nodes. Irritated thyroid nodule. Reported to primary care physician.
Information has been received from a health professional concerning a female who was vaccinated IM with the first dose of Gardasil (lot# not reported). Per the reporter the patient experienced a rash on her trunk 2 days after the first dose. The patient sought unspecified medical attention. The nurse did not have the patient's chart and could not find her chart during the phone call. No other information was available. Additional information has been requested.
persistant crying approx 4 hrs in length p/vax; mom noted pts eyes didn't seem to focus;
Fever >102 in AM after receiving immunizations.  Also noted that there was redness, swelling, and area was warm to touch.
Increasing warmth and itchiness s/p 24 hours.; Iincreasing warmth and itchiness s/p 24 hours.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; Booster; This is a spontaneous report from a contactable other health care professional, the patient. A 35-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 15Oct2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, anxiety and attention deficit-hyperactivity disorder (ADHD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid/ caffeine/salicylamide (EXCEDRIN); amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL); cetirizine hydrochloride (ZYRTEC); vitamin d nos (unspecified); escitalopram oxalate (LEXAPRO) and ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9265) via an unspecified route of administration in the left arm on 28Jan2021 at 15:00 as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation and experienced no adverse reactions for both the doses (reported as no noticeable symptoms). On 15Oct2021 at 23:00, the patient experienced a red symmetrical raised area around the injection site, warm to touch, extremely itchy. Noticed red, raised area status post (s/p) taking off a bandage. On 16Oct2021, status post (s/p) 24 hours, the patient experienced increasing warmth and itchiness. It was reported that if the physician's office were open, she would contact them with respect to the intensity of itching and heat of the arm. It was unknown if therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red symmetrical raised area around the injection site, warm to touch, extremely itchy, noticed red, raised area s/p taking off the bandage, increasing warmth and itchiness was not resolved at the time of this report.
COMPLETED VACCINES IN MARCH, 2021 - TYPE UNKNOWN ADMITTED TO HOSPITAL 7/11/2021 WITH NAUSEA, DIARRHEA , HA, BODY ACHES DISCHARGED 7/14
On Thursday (1 day after vaccine was administered) pt. developed a red area near injection site 2-3" dia. and itches. It resolves as for Saturday but still itches. Pt took ALLERGR. She states no allergies to latex or other ingredient.
G40.901 STATUS EPILEPTICUS 10/11/2022 CKD STAGE 3A (GFR 45-59) G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 CKD STAGE 3A (GFR 45-59) I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 CKD STAGE 3A (GFR 45-59) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 CKD STAGE 3A (GFR 45-59) I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 CKD STAGE 3A (GFR 45-59) G40.901 STATUS EPILEPTICUS 10/11/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G40.901 STATUS EPILEPTICUS 10/11/2022 SEIZURE, UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 SEIZURE, UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 SEIZURE, UNSPECIFIED I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 SEIZURE, UNSPECIFIED I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 SEIZURE, UNSPECIFIED G40.901 STATUS EPILEPTICUS 10/11/2022 HYPOKALEMIA G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 HYPOKALEMIA I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 HYPOKALEMIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 HYPOKALEMIA I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 HYPOKALEMIA G40.901 STATUS EPILEPTICUS 10/11/2022 CKD STAGE 3A (GFR 45-59) G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 CKD STAGE 3A (GFR 45-59) I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 CKD STAGE 3A (GFR 45-59) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 CKD STAGE 3A (GFR 45-59) I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 CKD STAGE 3A (GFR 45-59) G40.901 STATUS EPILEPTICUS 10/11/2022 ACUTE NON ST ELEVATION MI G40.909 EPILEPSY, UNSPECIFIED 8/16/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 5/27/2022 ACUTE NON ST ELEVATION MI I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/29/2022 ACUTE NON ST ELEVATION MI I82.4Y1 ACUTE DVT OF RIGHT THIGH, UNSPECIFIED VEIN 5/9/2022 ACUTE NON ST ELEVATION MI
Swelling, redness, swelling, and soreness at injection sight same day as injection. Five days after injection red spots on both arms and neck and hands. Reported to pharmacist Oct. 28, 2018. Selling and soreness receded in four days after injection. Red spots fading but still visible on Nov. 21, 2018.
did not return within the recommended time frame; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 18 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The patient did not receive the Shingrix at the pharmacy, so lot number, expiration date, and site of injection was unknown. The reporter consented to follow up.
Sudden and significant lower back pain in lubar region and localized without radiation to the legs.  Pain persisted 7/10 for first 12 hours from onset, gradually lowering to level of 2/10 over 48 hours and then 1/10 after 72 hours.   Onset of pain occurred without physical stress to the region (was quietly sitting in a chair).  Pain similar to when I herniated L5-S1 years ago (requiring hospital transport).   Pain was controlled to tolerable levels by immobilization (lie on floor with knees elevated, application of heat, and ibuprofen.   I did not associate this with the vaccine initially, but after consulting with my doctor, he recommended I report, as he stated there were some earlier reports about back pain with the similar Moderna vaccine, and there isn't a physical explanation otherwise as to why the sudden pain.
Pain, inability/refusal to move leg which he kept bent at the hip and knee, uncontrollable crying, redness, and swelling.  I gave 1 tsp Motrin at 9:00pm and then every 6 hours for 36 hrs.  He cried continuously until 4:04am when he fell asleep.  He woke at 7:40 am with a fever of 101.6° F.  He cried off and on throughout 12/12/2013.  He refused to walk for 30 hrs from onset of symptoms.
feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little bit out of breath; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 55 years old on 02Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling dizzy when he went to bed/dizziness occasionally throughout the day on 02Apr2021, feeling weak in Apr2021, a little bit out of breath in Apr2021. The patient was calling on behalf of her husband, the patient had first dose on 02Apr2021 and started feeling dizzy when he went to bed that night, he's dizzy when laying down in bed sometimes it woke him up, he had dizziness occasionally throughout the day and he was also feeling weak and a little bit out of breath. The patient was concerned on getting second. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax;exp 25-30 skin lesions;f/u indicated pt devel rash on 12aug95;eruptions were vesicles w/ erythema around them & typically looked like chicken pox;md does not feel pt had chicken pox;
8:40 am Tdap IM administered to (L) deltoid per MD. Pt observed x 15 minutes with no reaction reported. Pt discharged without incident. 9:20 am pt called to report hives, rash extreme urticaria, and shakiness.
Patient was admitted with progressive lower extremity weakness/possible GBS after receiving Moderna COVID vaccine. Records indicate that patient received the Moderna vaccine on 5/10/21 (lot 023C21A) and 6/7/21 (lot 038C21A). Patient was admitted after reporting symptoms of back pain for one month, progressive lower extremity weakness, pins and needles sensation in feet, and intermittent leg numbness. Symptom onset is reported as 9/15/21. Most recent neuro note states that GBS has been ruled out, but workup is ongoing.
Area size of credit card on upper L arm, red, warm, hard to touch, itching - Sneezing, temp 99-101 degrees - Alternating TYLENOL/ Ibuprofen - BENADRYL. Mother states it is the arm client pulled away during vaccination.
AROUND 11:00 NOTICED THAT LEFT ARM WAS RED, WARM, AND SWOLLEN.  GAVE 7.5 ML MOTRIN AND APPLIED ICE COMPRESS. BY 7.00 PM LEFT ARM WAS SWOLLEN, WARM TO TOUCH, AND REDNESS WAS 3CM BY 3 CM. ANSWERING SERVICE OF PEDIATRICIAN OFFICE CALLED FOR ADVISE.  AN HOUR AND 15 MINUTES LATER NURSE CALLED BACK, THE REDNESS HAD SPREAD AND AT THIS TIME WAS 3 CM BY 5 CM-EXTENDED DOWN TO ELBOW WITH COMPLAINTS OF ITCHING.  NURSE RECOMMENDED THAT DAUGHTER BE SEEN TO CHECK FOR REACTION.  DAUGHTER SEEN AT URGENT CARE WHERE MD DETERMINED THAT SHE WAS HAVING A LOCAL REACTION.  DAUGHTER RECEIVED A DOSE OF BENADRYL AT URGENT CARE AND WAS GIVEN A 5 DAY PRESCRIPTION OF A STEROID.
10/15/09 seen in office for redness, pain, swelling of L arm, itchy, afebrile. Tx: ice, MOTRIN. 10/16/09 T-100.6, redness and swelling increased and is itchy. Swelling from shoulder to proximal forearm, area warm and indurated. No streaking, normal pulses, tx: clindamycin.
A report has been received from a study investigator concerning a 39 year old, female subject, weight: 115.0 pounds, enrolled in study. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 06-Oct-2013. The patient experienced pregnancy which was started on 24-Sep-2013. The estimated date of delivery was 13-Jul-2014. The outcome of pregnancy was reported to be a healthy baby. The number of weeks at outcome of pregnancy was 38. The delivery was done by caesarean. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction). At the time of the report, VACCINATION SITE REACTION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
The rash at injection site was about 5 inches top to bottom; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was between 50 to 60 years. The patient experienced a very large rash in 2 areas on the arm where injection was given. The patient experienced injection site rash about 5 inches top to bottom and 2nd lower rash was about half dollar size. This case is 1 of the 2 linked cases, reported by the same reporter.
Initial and follow-up information has been received from a licensed practical nurse concerning a white, retired female whose reported weight was 90.6 Kilograms (kg) and whose reported height was 62 inches (in) who on 25-SEP-2006 was subcutaneously, vaccinated into the right deltoid muscle with a dose of PNEUMOVAX (Lot # 651400/0618F).  At 4:00 P.M. on 25-SEP-2006, the patient was concomitantly, vaccinated, intramuscularly into the left deltoid muscle with the second dose of DT Absorbed (Lot # U1847BA) (manufacturer Aventis Pasteur).  The patient experienced pain in the arm she received the PNEUMOVAX, and "a welt" at the injection site.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  In follow-up it was reported that the pharmacist requested a lot check for the PNEUMOVAX vaccine, (Lot # 651400/0618F).  The pharmacist wanted to know if there have been other adverse event reports with this vaccine.  The pharmacist will await the results of the lot check before vaccinating any more clients with the PNEUMOVAX vaccine that was left over from this lot.  A lot check of concern has been requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released by the regulatory agency.  In follow-up it was reported from physician office notes the following:  The patient was vaccinated on 25-SEP-2006 subcutaneously into the right deltoid muscle with a dose of PNEUMOVAX (lot # 651400/0618F).  The patient presented to the physician's office on 26-SEP-2006, with a 10 centimeter (cm) reddened, raised area on her right upper arm, below where the injection site was.  She stated that it was very tender and felt tight inside.  The physician looked at the area and wanted her to try diphenhydramine hydrochloride (BENADRYL) and apply a cold pack to the affected site several times a day.  The patient verbalized that she understood the plan of care.  It was reported that on 02-OCT-2006, the patient recovered.  Additional information has been requested.
Dose administered greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was reported.
7OCT96 mom reported scattered petechiae on thighs, underarms, hands, elbows 3wk p;/vax; 5 days later rash appeared on trunk;no fever or pruritus;no tx;pt is recovered;
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (lot # M000442 with expiry date 31-MAR-2018), was exposed to a temperature of 9.7 degree centigrade for a time frame of 1 hour, 22 minutes. There was no previous temperature excursion reported. The call was because of a date logger (therapy type: digital data logger) (Incorrect product stored). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Approximately 20min after receiving the first dose, L arm was already feeling heavy. Day 2-Greet deal of soreness in L arm. Day 3-Better. Day 5-Tingling sensation in hand/fingertips. Day 6-27-Intermittent bouts of heaviness in L arm, soreness at injection site, tingling in fingertips, shooting pain up L-side of neck.
Information has been received from a RN concerning a 4 yr old white male, with penicillin allergy and a history of asthma, who on 09Oct01 was vaccinated (unk route) in the right thigh with a first dose of varicella virus vaccine live (lot 639432/0787L). There was no illness at the time of vaccination. There were no relevant diagnostic test or lab studies performed. On 20Mar05 the pt experienced rash and lesions and was diagnosed with chickenpox. Subsequently, the pt recovered on 30Mar05. No additional information has been requested.