chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; arm was covered in a large red circle; hard; Reddish circle; tender; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Reddish circle), TENDERNESS (tender), PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  No treatment information was reported.  On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Reddish circle) and TENDERNESS (tender). On 05-Feb-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard). On 02-Feb-2021, INJECTION SITE ERYTHEMA (Reddish circle) had resolved. At the time of the report, TENDERNESS (tender), PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Reddish circle), TENDERNESS (tender), PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose #2. On 29-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Reddish circle) and TENDERNESS (tender). On 05-Feb-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard). On 02-Feb-2021, INJECTION SITE ERYTHEMA (Reddish circle) had resolved. At the time of the report, TENDERNESS (tender), PRURITUS (Itching), ERYTHEMA (arm was covered in a large red circle) and INJECTION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.
This child received Hepatitis B and MMR. After second shot the patients eyes rolled back in his head, the patient had LOC, became tense, had jerking movements, and was diaphoretic. The doctor and the nurse assessed the patient.
pt recv vax 16AUG96 & 31AUG96 pt devel a rash;
Within 4 hours of injection I was shaking with chills. The next morning I woke up with extreme fatigue, body aches, swollen armpit, and chest pain. My heart rate was high 120-140 for the first 3 days after my booster. Chest pain was intermittent for the first 5 days. Today is day 8 and I still occasionally feel chest pain when walking, but it is improved and my resting heart rate is again normal in the 50-70?s.
This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age and gender. The nurse practitioner inquired temperature excursion on 22-APR-2014 and there was no adverse event to report. The nurse practitioner reported again on 03-JUN-2014, on 30-MAY-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # J011882, expiration date 04-JAN-2015, 0.65 ml, subcutaneously) that was exposed to two temperature excursions, -5 C for 26 hours and -10C for 19 hours. No adverse effects were reported. Additional information has been requested.
Spitting up, screaming, not sleeping. Began within a few hours after injection and persisted since now 4 days out. Normal clinical exam. Fever 99.4F.
Received flu vaccine on a Thursday 10/9/2014 and Sunday 10/12/2014 I noticed my hearing was sounding strange.  When I awaken on Monday morning, the hearing in my right ear was completely gone.  I also experienced extreme vertigo, nausea, vomiting and the room spinning. There was also a lot of noise and ringing in my right ear.  On Tuesday 10/14/2015 morning I went to the ER because the nausea and extreme dizziness did not subside. They drew labs and performed a CT scan of the head and admitted me overnight for further observation.  I was also referred to an ENT for examination.
Diagnosed via biopsies conducted on 4/14, following a screening breast MRI on the date provided (4/1) with two types of precancerous conditions (intraductal papillomas (x2) and atypical ductal hyperplasia) in the right breast - the same side as where I received all three Pfizer Covid vaccines. There was no sign of either issue on previous scans, including a healthy report from a mammogram in Sept 2021 and my previous screening breast MRI in April 2021, which showed an enlarged lymph node only that was considered a normal reaction for the MRI taking place one week after receiving my second Covid vaccine dose in the same arm
Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 12:45 (Lot number: EN6203) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 06Feb2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Feb2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 27Feb2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 27Feb2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "unknown", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 27Feb2021, outcome "unknown", described as "dizziness"; PYREXIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 27Feb2021, outcome "unknown", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 27Feb2021, outcome "unknown", described as "sleep disturbance".  Additional information: No other vaccine were received in four weeks. The patient received Other medications in two weeks were supplements (unspecified) and no Rx. The patient experienced Headache, significant muscle aches, joint pain, nausea, significant fatigue, significant pain at the injection site, dizziness, fever, vision changes, sleep disturbance. These events lasted for at least 48 hours, some longer. No Covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts completed. No further information expected.
Patient was vaccinated on 1/14/2021.  On 1/22/2021, patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure, COVID-19 pneumonia, and severe ARDS.  Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures.
70 year old male received Hep A, Hep B, Typhim Vi and Tetanus/Diphtheria on 02/17/04.  On 02/27/04 developed headache, fatigue, loss of appetite, body aches.  Body aches resolved about 1 week ago.  Headache, loss of appetite, fatigue persists.
Approximately 6 hours following vaccination, patient experienced chills and a high temperature of 99.0F which passed after 36 hours. Approximately 12 hours following vaccination, patient experienced discomfort in external genitalia area upon wiping with toilet paper. Approximately 60 hours following vaccination, patient noticed three yellow-colored lesions on labia with extreme pain. Patient reports no recent sexual risk activity.
Severe pain in right arm at injection site; joint pain throughout body; severe headache; nerve pain in arms and torso; insomnia
Shortness of breath and cough started about 24 post vaccine. Symptoms continued and slightly worsened over next 48 hours.
Extremely sore arm (couldn't sleep because it hurt so much. Can't move the arm in full range because of the pain) Chills and dizziness (couldn't sleep!)
Chest/epigastric pain, resolved with Epinephrine 0.3mg x1, 50mg Benadryl slow IVP, 125mg Solumedrol slow IVP, albuterol inhaler 6 puffs.
Freezing hands the evening of the vaccine. Whole body freezing during night and fever, could not get warm enough. Also had shaking chills. A little better in the morning, took Tylenol in morning at which time temp was 100.8.  Symptoms recurred for 48 hrs with intermittent relief using Tylenol. Discussed occurrence with co workers and all who had prior covid and some variation of the same.
On 31Oct2023 she noticed that she had a welted red marks while she was in the tub; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of UNK, bid. At the time of the report, URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 31Oct2023 patient's mother noticed that patient had a welted red mark while she was in the tub. But reporter later noticed that they will disappear only to reappear in some other areas of patient's body - from her eyelids to the bottom of her feet and on her buns. Patient's mother gave her Benadryl initially but she noticed that there was no improvement after 2 days so she shifted to Allegra giving her 2x a day.  Patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-748711 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748711:different patient case
Her lower eyelid and it was swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Her lower eyelid and it was swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder NOS. Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced SWELLING OF EYELID (Her lower eyelid and it was swollen). On 28-Dec-2021, SWELLING OF EYELID (Her lower eyelid and it was swollen) had resolved.     When patient woke up on 23-Dec-2021, she touched her lower eyelid, and it was swollen. She did not do anything besides soak it. The next day it was worse. she went to the doctor, but the doctor did not help much. she couldn't see it anymore, so she didn't think much of it.   This case was linked to MOD-2021-435971 (Patient Link).
SHINGLES FACE; NOSE; EYE NOT INVOLVED TREATED WITH ACYCLOVIR 800MG 5X/DAY
Patient reports having arm soreness at injection site which has lasted over a month after vaccination. Patient states she is able to raise her arms over her head and the soreness/pain has improved, but still lingers. The pain has not worsened over time, but has improved over time.
small red rash along bilateral jawline that became itchy as time passed. 50mg Benadryl IM administered Right deltoid.
Pt presented to ER for chest pain, palpitations, shortness of breath which started within a few  hours of her Pfizer covid booster given yesterday on 10/26/21. She went home took tylenol/ motrin without relief. pt reported continued pain, shortness of breath, chest pain with rest and exertion worsened with laying flat improved with sitting forward constant since a few hours post administration of the vaccine so she sought care today. no cardiac hx in patient or her family
Narrative: Patient was tested positive for COVID-19 on 1/27/2022 while being an inpatient despite full vaccination. Pt did receive 2 doses of Pfizer and the booster on 11/30/2021
Brain fog; Difficulty with language/sentence formation; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 at 10:15 (Lot number: unknown) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration Time: 12:00; Anatomical Location: Left Arm; Route of administration: Unspecified), administration date: 08Apr2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Administration Time: 12:00; Anatomical Location: Left Arm; Route of administration: Unspecified), administration date: 29Apr2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 10:15, outcome "unknown", described as "Dose number: 3"; FEELING ABNORMAL (non-serious) with onset 15Dec2021 at 18:00, outcome "unknown", described as "Brain fog"; SPEECH DISORDER (non-serious) with onset 15Dec2021 at 18:00, outcome "unknown", described as "Difficulty with language/sentence formation". Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During a "wellness check up phone call" on 5/28, patient reported an increasing stiffness, pain near the injection site. Patient denied any itching, rash, discoloration, bruising or fever or general malaise. Patient reported he noticed the expected discomfort (2nd of the series) on Day 2, but that by the morning of Day 3, 5/28, upon awakening he was in considerable pain in the injection arm, but noted that the pain had subsided considerably after moving the arm and exercising.  Patient was advised to continue to move the arm as he was comfortable, take acetaminophen if desired, and report any ongoing issues.  Over the course of the next several days, via a couple of phone calls, the patient continued to report discomfort and patient was advised that the Pharmacist would consult with the manufacturer vaccine medical department for advice and that he might consider being seen by a physician is needed. Patient continued to state that the pain was the most intense early morning and subsided later in the day.  On or about 6/1 or 2, the Pharmacist did call GlaxoSmithKline and after conversation with the representative, and a review of patient symptoms, the representative advised that the symptoms were unremarkable per the drug profile and that in some cases the symptoms could remain ongoing for at least 90 days, per literature.  It was also discussed that the patient should seek other medical advice if he felt warranted.  Patient was called, information was shared and the patient seemed acceptable of the advice. There was no more report from the patient until the evening of 7/29, when the spouse of the patient reported that symptoms continued to linger and that patient had been seen and taken 2 courses of steroids, which relieved while medication was being taken but that symptoms returned after discontinuation of steroid.  Patient requested that the Pharmacist perhaps speak to the physician who was treating at present and the Pharmacist agreed to do so
There was an email rescheduling glitch, & has not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment with Paxlovid; COVID 19 Treatment with Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: fp7138) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: en6202), on 23Mar2021 as dose 2, single (Lot number: ep6955), on 25Oct2021 as dose 3 (booster), single (Lot number: ah8020) and on 06May2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment with Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No known allergies. The patient received Paxlovid treatment from 10Dec2022 to 15Dec2022.
3 inch by 4 inch area of urticaria, beginning 2 inches below injection site. Mildly  pruritic.  May have begun prior to reported date but noticed 10 days after vaccination.
Very mild headache, infrequent mild chills, aching in extremities of the toes, heel of right foot, shoulders, and middle of body around the waist and hips lasting for 7 hours quite intensely, then tapering off quickly. The next morning still had very mild headache and lethargic all day long.
RED SPOTS ON PUBIC AREA; TINY RED SPOTS UNDER RIGHT BREAST AND TWO ON RIGHT ABDOMEN WHICH ARE GETTING MORE REDDER AND PROTRUDING MORE; RED SPOTS ON BACK AND RIGHT FOREARM; TWITCH OF PAIN TO LEFT BREAST OR HEART AREA; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 134 pounds, and height was 54 inches. The patient's concurrent conditions included non smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no drug abuse/illicit drug usage and no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced twitch of pain to left breast or heart area. On 16-MAY-2021, the subject experienced red spots on pubic area. On 16-MAY-2021, the subject experienced tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more. On 16-MAY-2021, the subject experienced red spots on back and right forearm. Laboratory data included: Coagulation test (NR: not provided) Refer result unstructured data, and Complete blood count (NR: not provided) Refer result unstructured data. The action taken with covid-19 vaccine  was not applicable. The patient recovered from twitch of pain to left breast or heart area on 27-APR-2021, and had not recovered from tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more, red spots on back and right forearm, and red spots on pubic area. This report was non-serious.
asymptomatic abnormal liver function tests (on routine testing) moderate acute cellular rejection on liver bx admitted to hospital, treated with steroids and additional immunosuppression