chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a large blotchy red rash has broken out on the left side of my face and neck; a large blotchy red rash has broken out on the left side of my face and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "not recovered" and all described as "a large blotchy red rash has broken out on the left side of my face and neck".  Additional information: After receiving covid booster a large blotchy red rash has broken out on the left side of face and neck. It has lingered now for three weeks since patient had the shot. Patient was little concerned and unsure what can be done to get it to go away. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%)."For any specific questions regarding the risks of the vaccine based on your medical condition or treatment recommendations, please speak with your healthcare provider.  The lot number for bnt162b2 was not provided and will be requested during follow up.
At 8:30 AM, the patient received the vaccine in her left arm. At around 8:43, she complained of feeling dizzy and notified our vaccine administrators. She started to show facial redness and by 8:45 AM she had hives on her neck which radiated down to her chest. At that time, we administered benadryl 50 mg orally x 1. Took some vitals (Pulse ox = 98%; HR 92; BP 160/102). Then, wheeled her to emergency room for further monitoring.
patient presented to pharmacy requesting covid vaccine and answered no to having received a vaccine previously. pharmacy checked state registry and there was no record of patient. upon billing after administration medicare rejected stating  it had previously been billed. we confirmed with medicare that he had received 2 doses previously. contacted patient following day and confirmed that her husband was a physician (who also presented same day for booster dose) and intentionally lied on the consent form  in attempts to obtain a 3rd booster dose which she was aware he was not approved to receive. when informed that she was not approved she reported that side effects to 3rd dose 24 hours our were similar to those following 2nd dose. patient did not call to state an adverse reaction, pharmacy is reporting because she lied to obtain 3rd unapproved dose
pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pain  (non-serious) on an unspecified date.  Therapeutic measures taken as a result of pain included 3 ADVIL. Caller reported taking 3 advil after receiving vaccine due to pain not related to vaccine, her pain was related to swimming.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, a possible contributory role of vaccination with BNT162B2 in the development of the event pain cannot be excluded.
Patient was given the Pediatric Dose of Moderna 6m-5years 0.5 ml  instead of the Moderna Bivalent vaccine.
9p day of injection started fever and soreness at injection site. Fever rose to 101.2 at 3am and decreased to 99.8 by 10am. Fever increased to 100.6 again in evening and dissipated by morning. Left side muscle aches especially in spine and lower leg area started at approx. 11pm day of injection and are continuing into the third day including injection day. Also had Lt side muscle issues in knee and arm November 2020 but no other symptoms so no covid testing done. Doctor assumed it was sports injury related.
None. Patient administered vaccine that was outside her age group. *No reaction as of today 11/7/16.
Temperature excursion for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nurse assistant referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown day in August 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038698, expiration date 01-DEC-2021, 1 dose for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported). It was reported that on 11-AUG-2020 temperature excursion occurred for vaccines that were administered to patients after the excursion occurred (product storage error). The temperature was -10.2 degrees Celsius (C) with a time frame of 1 hour and 53 minutes; there was no previous temperature excursion, and a digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
22JAN febrile seizure - turned blue/convulsed, 21JAN child shook all over- mom thought it was just chills.
threw up heavy/ vomited; Heavy diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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: VOMITING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "threw up heavy/ vomited"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "Heavy diarrhea". Additional information: Events were reported to occur 2 days after the initial BNT162B2 vaccination. Heavy vomiting lasted 2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My son received the PREVNAR vaccine at approximately 9:30 am on 10/22/2016.  That evening, patient was unable to sleep throughout the night which is unusual. On the morning of 10/12/2016 I noticed a red mark at the site of the injection and a large, hard lump under his skin approximately the size of a quarter - fifty cent piece. Each night since the vaccine was administered, my son is unable to sleep, and continues to wake up crying. Before the vaccine, my son was a good sleeper, and slept through the entire night (approximately 8-10 hours). I contacted the pediatrician office on 10/12/2016 and was told what type of side effects to look for but was not given an answer as to why he had a hard lump under his skin. The nurse on the phone said it may have been the result of pain. My son is scheduled to have the lump examined today at 3:50 pm.
Facility type is Health Center. Medical Assistant entered the wrong date in XCIR for pediatric patient that received Hepatitis A which cause the patient to receive a second dose of Hepatitis A. The initial dose was considered invalid by XCIR and showed the patient was due for Hepatitis A. To prevent this error from recurring it was discuss that the medical assistant make sure to be careful when enter vaccines in XCIR, take extra time and verify all the information that is entered into MCIR is correct before submitting it.
Received vaccine on 27Dec2019. Lymph nodes swelling and pain, Low grade fever, tenderness in shot area and under my arm
2 doses of Hep B given at visit on 2-16-2021, 1 dose of Energix-B by GSK  and 1 dose  of Pediarix  by GSK.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Came to ER with fever, generalized weakness starting on 8/7/2021. Temp of 101.9, Saturating 90s on 2L NC. Patient was drowsy and alert and oriented x 1. Received azithromycin and ceftriaxone. Admitted to the hospital. Through stay was treated with supplemental oxygen, Decadron, azithromycin, ceftriaxone.Over the course of hospitalization patient was successfully weaned off the oxygen.  Had no noted fever spikes.  Was breathing on room air.  Finished antibiotics and steroids.  Patient was taken of isolation precautions before discharge based on institutional protocols. discharged to SNF on 8/18/21
About one hour after vaccine was administered, my left forearm and left hand started to tingle. My  hand then felt numb or as if it were ?asleep.? I called the pharmacy and was advised to take Benadryl. I took 25 mg of Benadryl around 10:15. Around 10:20, my throat began to feel ?small? or as if it were getting tight or closing. Around 10:40, my throat felt normal but my arm and hand was still tingly and numb feeling. Today, my hand has felt like it is ?asleep? all day.
While administering a vaccine from a prefilled syringe. The nurse was pushing in the plunger with her thumb & holding the finger grip with her index & middle fingers, the white finger grip actually fell off the syringe, into my hand while I was administering the vaccine and pushing in the plunger.
Patient states after getting vaccine she slept for days, had a lot of dizziness, was very tired, had a headache, stomach discomfort and diarrhea, had a very large red spot on her arm that finally went away on 7/21/21
approx 3 wks p/vax fever, serum sickness, muscle pain, joint pain, joint redness & swelling severe rash, severe h/a, body swelling, latr dx CFS; poss encephalopathy; elevated IgM; poss inc IgG;
190 patients (9 different lot numbers) received a vaccine past the beyond use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Covid-19; Patient had 6 days of fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) and PYREXIA (Patient had 6 days of fever) in a 3-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19) and PYREXIA (Patient had 6 days of fever). At the time of the report, COVID-19 (Covid-19) outcome was unknown and PYREXIA (Patient had 6 days of fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.   Reporter stated that she got the Covid for the patient who came from a trip. Patient was vaccinated however the reporter was not sure whether it was Moderna or Pfizer  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660892, US-MODERNATX, INC.-MOD-2022-660889 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660892:daughter case US-MODERNATX, INC.-MOD-2022-660889:son-in-lawcase
10/5/00 Until Present Fever Swelling at site Lost Speech Spinning Hand Flapping High Pitched Screaming When Upset Real Sensitive To Noises Started Losing Balance And Easily Falling Easily Agitated And Irritable For No Reason Easily Upset When Situations Or Surroundings Are Changed Unresponsive To Name Or Simple Questions Detachment From Other People Hitting And Pinching, Especially In The Face, Neck, And Under Arm Personality Changed Stopped Sleeping Through The Night Repeats Words Or Starts Words Over And Over Does Not Stop Doing Something Wrong When Told Repeatedly To Stop Clings To Mom Most Of The Time Will Not Let Anyone Else Do Anything For Him But Mom Feet Are Always Hot and Sweaty With Shoes On Left Eye Occasionally Crosses Slightly
hives; itching; rashes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and RASH (rashes) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (hives), PRURITUS (itching) and RASH (rashes). At the time of the report, URTICARIA (hives), PRURITUS (itching) and RASH (rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
ITCHY AT INJECTION SITE; RED AT INJECTION SITE; PAINFUL AT INJECTION SITE; SWELLING AT INJECTION SITE; WARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 13:10 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced warm. On 11-MAR-2021, the subject experienced itchy at injection site. On 11-MAR-2021, the subject experienced red at injection site. On 11-MAR-2021, the subject experienced painful at injection site. On 11-MAR-2021, the subject experienced swelling at injection site. Treatment medications (dates unspecified) included: hamamelis virginiana extract. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful at injection site, had not recovered from red at injection site, itchy at injection site, and swelling at injection site, and the outcome of warm was not reported. This report was non-serious.
Pt's mother states pt c/o numbness that started in her fingertips, moved down her arms to her face, lips, mouth, throat and ended.  Ha/migraine. Pt was nausious, sensitive to light, shakey.  Pt was seen by Dr ct scan done.  Symptoms started at 7:00am on 2/26/07 and pt remained tired until 3/1/07.
25 Aug when he was 2 weeks post smallpox immunization was for concern regarding the (expected) black crusting at the site. He had significant pain 6/10 in left axilla and spine. No headache, fever, chest pain, SOB. Person confirmed that on 30 Aug the patient was much better with only axillary pain 2/10.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.15  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Dizzy; cough; Rib pain; Urine output down; Pulse OX 94 (normal pO2 is 95); Bowels felt crampy; He was unable to get out of bed; Appetite down; Persistent fever up to 102 F.; Nausea; Headache; Extreme chills.; feeling sick.; Body aches and pains; He began feeling fatigued; A spontaneous report was received from a dietician concerning a 57 year-old, male patient experienced fatigue, extreme chills, body aches and pains, persistent fever, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, decreased pulse ox, and bowel cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to feel fatigued. On 25 Dec 2020, he was feeling sick and by that night had extreme chills, and body aches and pains. On 26 Dec 2020, he had a persistent fever up to 102F, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, and bowel cramping. His pulse oxygen saturation was reported to be 94 percent. Patient was unable to confirm COVID-19 exposure. Treatment for the event included paracetamol, prochlorperazine, and dextromethorphan hydrobromide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
EDEMA, WARMTH AND TENDERNESS.  WARM COMPRESS AND KEFLEX ANTIBIOTICS.  EDEMA ENTIRE UPPER ARM.