chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Palms of both hands became inflamed; Itching; Felt like they were put on top of a hot stove; Intense burning; palms of both hands became inflamed red; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning) and PALMAR ERYTHEMA (palms of both hands became inflamed red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction). At the time of the report, INFLAMMATION (Palms of both hands became inflamed), PRURITUS (Itching), FEELING HOT (Felt like they were put on top of a hot stove), BURNING SENSATION (Intense burning), PALMAR ERYTHEMA (palms of both hands became inflamed red) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient had other reactions but did not want to mention them and doctor told her to wait 3 months between vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Had well check and routine vaccines in the morning. In the afternoon in mom's arms he felt feverish. She took him to his room to check his temp and he went very pale & limp (not blue). Eyes rolled back. No shaking or obvious seizure activity. Was breathing very short/shallow breaths. Then was fine. 911 called - vitals normal was admitted to hospital for observation.
This case was reported by a other health professional via call center representative and described the occurrence of asthmatic attack in a 19-year-old female patient who received BEXSERO (batch number 148901A, expiry date 30th September 2016). On 31st August 2015, the patient received BEXSERO .5 ml. In September 2015, several days after receiving BEXSERO, the patient experienced asthmatic attack. On an unknown date, the outcome of the asthmatic attack was recovered/resolved. It was unknown if the reporter considered the asthmatic attack to be related to BEXSERO. Additional details were received as follows: In September 2015, few days after receiving BEXSERO vaccine, the patient experienced asthma attack. The date when patient experienced asthma attack was not available.
Awakened from normal sleep by something similar to restless leg syndrome (which "I" don't have) accompanied by pain all over body; Awakened from normal sleep by something similar to restless leg syndrome (which "I" don't have) accompanied by pain all over body; Couldn't find any position that "I" could stay in for more than a few seconds. "I" couldn't tolerate the pressure of the bed on any part of body; Felt acute pain in the rib area of back on both sides; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the right arm on 14Sep2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor, chronic back pain, and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL), and curcuma longa (TURMERIC), unspecified vitamins and minerals; all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received hydrochlorothiazide (HCTZ) on an unknown date for unknown indication and experienced drug allergy. On 14Sep2021, the patient experienced mild nausea, which the patient had since getting the shot. On 16Sep2021 at 00:00, the patient was awakened from normal sleep by something similar to restless leg syndrome (which the patient did not have) accompanied by pain all over the body, the patient could not find any position that the patient could stay in for more than a few seconds. The patient could not tolerate the pressure of the bed on any part of the body and the patient felt acute pain in the rib area of the back, on both sides. The patient tried walking in place, back, stretching exercises, etc but nothing worked. The patient finally tried autogenic relaxation focused on the brain, the patient's brain was calm and was able to fall asleep. The patient estimated that this lasted about 30 minutes. 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 event nausea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events awakened from normal sleep by something similar to restless leg syndrome (which the patient did not have) accompanied by pain all over body, could not find any position that could stay in for more than a few seconds could not tolerate the pressure of the bed on any part of body, felt acute pain in the rib area of back on both sides, and mild nausea was unknown at the time of this report.
This is a spontaneous report from a contactable other healthcare professional (physician's assistant). A 65 year-old female patient received the first dose of PREVNAR 13, (lot S74424) via an unspecified route of administration on 01Jun2018 at 0.5 ml single in the right deltoid for routine vaccination. Medical history included ongoing allergy to penicillin and irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant vaccine administered on 01Jun2018 for immunization included the first dose of SHINGRIX, (lot XC534) in the left deltoid. The patient had previously received for immunization another varicella zoster vaccine in 2016 without any adverse event. The patient experienced red, bumpy, itchy area around injection site on an unspecified day in Jun2018, she also experienced rash on left neck, arm, and knee on 08Jun2018. Clinical course was as follows: the patient reported induration after the vaccine and she had a red, bumpy area around the injection site. The patient was visited on 07Jun2018, she had a worsening red, bumpy area around the injection site, her arm was sore, and the itchy area which started out as the size of a 50 cent piece was getting bigger. The rash got bigger and was warm to the touch. The reporter was not sure when these symptoms first started for the patient. The patient was prescribed with BACTRIM and KEFLEX in case of infection.  On 08Jun2018 the patient had a similar rash on her left neck, arm, and knee. The rash on the left side of the patient's body did show up after she took sulfamethoxazole, trimethoprim. The reporter was not sure if the patient was scratching, and that also contributed to the rash or not. The patient was not recovered from red, bumpy, itchy area around injection site and rash on left neck, arm, and knee that were reported as worsened; outcome of other events was unknown. The events red, bumpy, itchy area around injection site and rash on left neck, arm, and knee were assessed as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Report 20010190851 described arthralgias in a 45 year old female who received Lymerix. On March 13, 2001 the pt received a 0.5 mg IM dose of Lymerix, it was not known whether she received a previous doses of Lymerix. On March 14, 2001 the pt experienced arthralgias and fatigue. Lymerix was discontinued. As of August 7, 2001, the outcome of the adverse event was unknown. The adverse event of 'arthralgias' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
No adverse reaction. Member received first dose as Pfizer at Disney location. We administered her Moderna for her second dose.
Fever, headache, chills, aches within 24 hours of receiving vaccines. Very strong cramps and heavy flow two following menstrual cycles after vaccination (about 2 and 6 weeks after vaccination).
Client presented to the clinic on 2-11-2022 for a booster vaccination after his initial J+J vaccine. The client reported that he was immunocompromised s/t to Humira use for ulcerative colitis. He requested Moderna (lot number 013H21B) and received it to LD at 1539.  However, due to a misunderstanding of current guidelines on the part of clinical staff, the client received the full dose of Moderna (100mcg/0.5mL) instead of the standard booster dosing of 50mcg/0.25mL. (The Charge Nurse came to this writer to ask whether the client would be eligible for a ?booster? dose after this dose of Moderna s/t his status as an immunocompromised client. It was discovered that he had received a full dose instead of the booster dose during this discussion.) The on-call physician, was informed of the situation and stated that it was unlikely to be a safety concern. He also expressed that changes to dosing guidelines for immunocompromised clients after initial J+J vaccinations were currently under consideration and that the client may in fact become eligible for a booster after this full-dose vaccination, if the guidelines are adopted. The client was made aware that he had received the full dose instead of the booster dose and that this was unlikely to be a safety issue, but that it didn?t adhere to the current clinical guidelines or Standing Orders. The client verbalized understanding of the situation and the provided education and reported that he had no questions or concerns at this time. He complimented the staff and his experience in the clinic generally. He was provided with contact information so that he could reach out if he had any further questions or concerns.  The staff members involved were educated/coached on current guidelines regarding immunocompromised clients presenting for booster doses after their initial J+J vaccinations. Additionally, all clinical staff members were educated on the current guidelines for immunocompromised clients/booster doses during the end-of-day huddle.
has not had her period since May; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 28Mar2021 at the age of 46-year-old, as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS, Had it for over 20 years now) from 1998 and ongoing, lost vision because the MS progressed (taken a lot of her vision. She could still see, but not good at all), it was even worse now and she was legally blind, she couldn't see and drive any more and needed a magnifying glass. She had hearing loss, bowel movement issues, and urinary but those are MS things too. The patient's concomitant medications were not reported, nothing new within two weeks of having her last period in May. The patient previously received first dose of BNT162B2 in left arm on 07Mar2021 at the age of 46-year-old for covid-19 immunisation. The patient reported that she did not have her menstrual cycle sine May2021. She had a history of multiple sclerosis, and was disabled, her doctor did not think she was going through menopause. The last menstrual period started on 12May2021. She has not had her period since May2021. Her average weight was around 140. During COVID quarantine the gym was closed and she was not exercising as much, so she gained some weight. She had a physical trainer due to her vision. She couldn't believe the period. She hated her period and couldn't stand it. She has more health here. When she went to her MS doctor, they took her normal blood because of medications she was on. When she was at PCP, she took her blood. She gave blood test to check to see if she was pregnant. She was just being precautious. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient states evening on 11/11/18 she experienced pain and swelling on her right arm from her shoulder to her elbow. She put a heating pad on it. Pain/swelling/arm mobility issues in AM of 11/12/18 and called MD and pharmacy. MD instructed her to take TYLENOL. Pharmacy instructed her to take TYLENOL, cold compress, elevation, and movement. Patient states no redness, no fever, and no discharge. Instructed her to go to MD/ER if symptoms worsen.
Cramping she had is similar to the one she has on day one of her period; Back hurts; Period two weeks after completing previous; Brownish spotting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting). At the time of the report, MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (lot # 655617/1447F) 0.5 ml injection. There was no concomitant medication. On 09-FEB-2007, the patient experienced swelling, tenderness, and redness in the injection site after receiving her first Gardasil dose. The patient sought medical attention. The next morning, the clinic administered 50 mg of BENADRYL and "it went back to normal". The nurse practitioner did not mention if it was because of the diphenhydramine. Subsequently, the patient recovered. They plan to give the second shot. Additional information has been requested.
Whole body pink macules, entire chest, back, legs, upper lower, and upper arms are confluent, entirely covered, slightly elevated. Lips are red, mildly swollen. 1 oral ulcer.  Given 125mg of Solu-Medrol and Prednisone course.
Arm soreness at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 58-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 17Mar2021 at 15:00 (at the age of 58-year-old), as single dose for COVID-19 immunisation. The patient medical history included asthma. Concomitant medications included Allegra, vitamin D (MANUFACTURER UNKNOWN), Afrin decongestant nose spray for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:15, the patient experienced arm soreness at injection site. The clinical outcome of event arm soreness at injection site was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Improper storage of product in use; no adverse event; This spontaneous report was received from an office manager referring to a 13-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 09-FEB-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact lot# and expiration date were not demonstrated, but was reported as: lot#: 1775811, expiration date: 07-DEC-2023; lot#: 1775827, expiration date: 27-JUN-2024; lot#: U032681, expiration date: 26-OCT-2023; lot#: 1780876, expiration date: 09-NOV-2023;lot#: W009829, expiration date: 19-OCT-2024) for prophylaxis using private funds at a private doctor's office/ hospital. The vaccine administered experienced 8-minute temperature excursion on 09-SEP-2022, 5-imnute temperature excursion on 14-SEP-2022, and 12-minute temperature excursion 03-JAN-2023 (product storage error). The excursions were due to employee error of cleaning data logger more than once a day. No adverse event occurred on the patient (no adverse event).
Moderns COVID-19 Vaccine EUA  Upon injection, the site was very sore for 3 days with fever chills and then went away. On day 11 i developed covid arm with a large circular welt that was itchy and extremely hot. On day twelve until still today I have a slight rash with extreme itching, sore muscles, sore joints (all my joints), and fever/chills.
Headache, Myalgia & Fever Narrative: Patient reports experiencing symptoms of headaches, body aches, and  fever (102 F) beginning the day after receiving the second dose of the vaccine.  Denies any previous reactions to any prior vaccines. reports used Tylenol (no dose/frequency provided)  for symptom relief. Did not report to PCP or urgent care for symptoms.
Left leg uncomfortable to walk; Can feel pain in my bone; Injection  pain; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Left leg uncomfortable to walk), BONE PAIN (Can feel pain in my bone), VACCINATION SITE PAIN (Injection  pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016BZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced GAIT DISTURBANCE (Left leg uncomfortable to walk), BONE PAIN (Can feel pain in my bone), VACCINATION SITE PAIN (Injection  pain), HEADACHE (Headache) and MYALGIA (Muscle pain). On 03-Apr-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, GAIT DISTURBANCE (Left leg uncomfortable to walk), VACCINATION SITE PAIN (Injection  pain) and HEADACHE (Headache) outcome was unknown and BONE PAIN (Can feel pain in my bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received on 19 JUL 2021 does not contains any  new information
Sore arm...up at night...frequent urination...headache...low-grade fever...slight nausea...aches. Took ADVIL thirty minutes ago.
c/o red raised rash at left shoulder at about 1:00 p.m. on 12/3/09.  Red rash spread to back and trunk that evening and continued until 12/3/09 when he called the Health Dept. Referred to physician. Was seen at clinic, who thought it resembled shingles, but it crossed over to other arm. Was given a Rx that reduced the swelling and discomfort.
Symptoms began less than 24 hrs. after receiving inject. upon waking in the AM 6/23/11. (R) arm at inject. site was sore and swollen - Later becoming red & hot (later in the day), then starting to itch off & on the next day - 6-24-11. Site/(R) arm would become less red & feel warm alternately with darker red & hot.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-FEB-2016 the patient was vaccinated wit M-M-R II (dosing details were not reported) lot # L015282 with an expiry date 30-APR-2017 which was improperly stored at 47 F for a time frame of less than an hour. There was no previous temperature excursion. No information was provided regarding concomitant medications. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Pt called c/o seen in health care after hours clinic child with fever, large red swollen area right thigh size of soft ball. Fever over 100 states Dr. Said infected injection sites. No pus or blisters. Put on Augmentin seen in out pt 09/23/2004 shots given 09/22/04.
Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later; The patient was injected with Moderna's COVID-19 vaccine in error; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient was previously admitted for non-COVID related reasons.   The patient was previously vaccinated with J&J Covid-19 vaccine on 09-Jun-2021 via Intramuscular route (batch no. 207A21A, location LD). The reporter stated that they were initially unaware that the patient had received the J&J vaccine but learned about the J&J vaccination after the Moderna dose was given. The patient was fully vaccinated and currently had no untoward effects.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received. Updated Patient Race and ethnic group, Dose 2 details.
The child became very pale, nauseated, and weak after vaccine given around 3 PM; within 5 minutes. The patient had nothing to eat since breakfast. The patient was given apple juice and told to lie down, then left within 15 minutes.