chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painless but red and slightly swollen round rash  appeared 10 days after receiving 1st. dose of Moderna vaccine..    Feels warm to touch.  Slightly itchy.   (The day of vaccine  I had achy arm but no rash)
Swelling, erythema and heat at the sight of vaccine on right arm 2 days following immunization
1st one in 2014 and 2nd on 2018; 1st one in 2014, 2nd on 2018 and a 3rd dose on 2022; The reported third dose had expired; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in an unknown date in 2014).   On 18th February 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long, expired vaccine used and drug dose administration interval too long were unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that a patient received 3 doses of Twinrix, 1st dose received in 2014, 2nd dose received in 2018 and 3rd dose received later than the recommended interval, which led to drug dose administration interval too long. The reporter reported that 3rd dose had expired on 08th February 2022, which led to expired vaccine used.  The reporter consented to follow-up.
This spontaneous prospective pregnancy report was received from a female patient (who was also a nurse) of unknown age. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with GARDASEIL (dose, frequency and lot # were not reported). Concomitant medications were not reported. It was reported that 2 weeks prior to her discovering that she was pregnant, the patient received GARDASIL vaccine. It was unspecified which dose with in the series the patient was received. The patient became pregnant. The LMP and EDD was not known. The pregnancy outcome was unknown. No product complaint was reported for GARDASIL. Additional information has been requested.
10-15-18 10:15pm acute severe swelling-prednisone 60 mg x 3 days, loratadine 10 mg daily, famotidine 2 mg daily. Localized to (R) deltoid PCV 23 vaccine.
The following day after administration (January 11), she said she broke out in hives and itching along her back and both shoulders in the evening. She says that every night since, she breaks out in hives and experiences itching along those areas and her scalp. But it resolves in the daytime.
Fever; Chills; Body ache; This is a spontaneous report from a non-contactable consumer (Patient). A 34-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 17:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 34 years). Medical history included Chronic Pleurisy, Thalassemia Beta. No other vaccine in four weeks. No other medications in two weeks. The patient's concomitant medications were not reported. No covid prior vaccination. The patient did test covid post vaccination. No known allergies. On 23Feb2021 06:00 (approximately 12 hours after vaccination) patient experienced fever, chills, body ache (all parts of the body). The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 08Feb2021. No treatment required for event. The outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VARIVAX lot # M008171/expiration date-16-FEB-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Developed Shingles. Was prescribed medication to treat shingles and after a few weeks shingles went away.
Itchy rash; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol blood excessive and Allergy NOS. Concomitant products included LORATADINE (ALLERCLEAR) for Allergy, WARFARIN for Anticoagulant therapy, EZETIMIBE, SIMVASTATIN (VYTORIN) for Cholesterol blood excessive, FUROSEMIDE for Diuretic therapy, LOSARTAN for Hypertension, VITAMIN D3 for Loss of energy, POTASSIUM CHLORIDE for Potassium replacement, CINNAMON [CINNAMOMUM VERUM] for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) outcome was unknown.            Patient stated that she developed rash as big as her palm that was red and itchy.   Action taken with mRNA-1273 in response to events was not applicable.
Rapidly enlarging area of erythema/induration locally at site of administration. When seen 24 hours after administration hot to touch. Possible cellulitis versus vaccine reaction. Started on Keflex.
My period started 1 week early. I take birth control so this is not normal. I had horrible bleeding, cramping, and pain. My period has not stopped and it has been 7 days. It usually only lasts 4 days.
The day after the vaccine, patient experienced chills, body aches and headache that lasted approximately 72 hours. On day two, patient noticed sore lymph nodes in one arm pit. On day three, patient noticed rash on one side of buttocks.
got sick; can receive the vaccine at this time or not since it been more than 42 days; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days) 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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days). At the time of the report, ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Subject: COVID-19 Vaccine I received my COVID-19 vaccine (right arm)  on January 24, 2021 at 2 pm. The purpose of this note is to let you know that on Saturday 1/23 i started having sharping (icepick) pains in my head -right side, behind ear and the pains are continuing today 1/25/2021.
they gave her son Pentecal that was 6 days expired; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 12 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that they gave her son Pentecal that was 6 days expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported and expiry date: 10-Oct-2019 via intramuscular route in leg.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Information has been received from a physician concerning a 5 year old female who received her first dose of MMR II at 15 months of age (approximately 2005) and developed idiopathic thrombocytopenic purpura. The patient sought medical attention. The patient recovered after treatment. Upon internal review, idiopathic thrombocytopenic purpura was determined to be an other important medical event. Additional information has been requested.
On 5-1-2012 parents stated patient had seizure went to the Emergency Room this was 2nd seizure. 1st seizure may have happen few weeks earlier. Since day immunizations given 3-1-2012 (L) arm has hurt - now feel she has altered sensations in her (L) arm.
Approximately 3-5 minutes after vaccinated the patient collapsed and had what appeared to be a grand mal seizure.  He was in the waiting area with his family. Pharmacy staff wasn't there to witness the start of the seizure but it appears that his mother recognized the symptoms and helped him to the ground on his side and managed to protect his head and extremities. It probably lasted around 2-3 minutes before the patient regained consciousness and seemed relatively alert and oriented. EMS arrived shortly after and he was transported to the local hospital. He was able to stand up with some assistance to get into their stretcher. Patient's mother mentioned afterwards that he had a seizure in the past when he was 9 years old after a flu immunization.
PATIENT HAS RECEIVED BOTH PFIZER COVID-19 VACCINE, TESTED POSITIVE TO COVID-19 8/11/21, AND ONSET OF SYMPOMS ON 8/2/21
Experiencing progressive weakness and numbness in arms and hands.  Legs feel heavy. Hands become stiff and freeze in position, occasionally cramping.  I've described the arm and leg sensations as "dead arm" and Heavy legs.  Also have a feeling in them that I can't describe.  I started paying attention to this in early March.  Now it is frequentseveral times a day lasting for 15 to 20 minutes.
About  4-5 hours after her first shot she started getting and itchy feeling.  This carried on for the next several weeks.  She felt like the itching feeling may have improved a little just a couple days prior to her second vaccine, but then the symptoms came back even worse after her second vaccination. She saw her primary care and was noted to be very jaundiced.  She was sent to the emergency department where her bilirubin was greater than 12.  She ultimately was admitted to the hospital.  She had no abdominal pain, nausea, or vomiting.   She had persistent elevation of her bilirubin.  Workup was done during the hospitalization including lab work, MRI of the liver, liver biopsy.  She was also found to have choledocholithiasis on the MRI.  ERCP was done with  stone extraction.   Bilirubin trended down several days later to around seven.  She followed up with me in the office where repeat lab work was unchanged.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). No concomitant therapy was reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Soreness, redness, swelling, heat at injection site and extending over a larger area of triceps area.
No adverse effects reported; patient received second dose in Varivax series that was improperly stored.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions, and concurrent conditions were not disclosed.  On 23-JUL-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, anatomical injection site and route of administration were not disclosed), lot # R020650 and expiration date 18-JUL-2020, for prophylaxis. This vaccine was diluted with a properly stored sterile diluent.  It was reported that this vaccine had been on a temperature excursion that started in April 2019, and was stored at 7.7 °F during 30 minutes. It was also noted that there had been a previous temperature excursion, and the vaccine had been stored between 6 °F and 14 °F, for 188 minutes.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
10 minutes after receiving the above vaccines, patient complained of nausea, lightheadedness and feeling lie had trouble with vision. PT was noted to be pale, clammy and diaphoretic. Pt was answering question but very slow to respond. Denied pain anywhere. PT initial BP before vaccines 102/60 HR 67. After vaccines when ill. Pt had BP 78/56, HR 84. Initial pulse ox 95% on RA.Pt was slow to recover and continued to have low BP and appear pale. Pt BGT 95. PT given  Few small sips of water. EMS called to transport to hospital for further evaluation. Dad agreed to plan. Dad reports he has not had previous vaccine reactions. Pt hx unremarkable. Biological father does report he himself had episodes of passing out as a child.
On 02/02/2001, the infant woke this AM with right leg swollen at the site of vaccine. Red and has knot under skin. The god parent took the child to the MD.
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day.  Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening  and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good  on 4/7  but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I  called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
according to patient, after 3 days, patient  had raised uneven lump at the injection site, the lightest touch would hurt it. patient was feeling very lethargic. Patient went to urgent care and  According  to patient, doctor mentioned that the area looked like cellulitis and was prescribed keflex 500 and mupirocin ointment
Headache, Myalgia, Diarrhea, FATIGUE, CHILLS, LYMPHADENOPATHY Narrative:
Tiredness; Headache; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information included: The report was not related to a study or programme. The patient received Pfizer vaccine on few days ago (Tuesday). The patient had been tired the last couple of days and diarrhoea was on another day. He asked how long would that last as he wanted to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 04/28, MODERNA, dose #1 (non-facility) 05/28, MODERNA, dose #2 (non-facility) 12/27 COVID swab, result: detected 12/23 pt cc: cough, rhinorrhea, sore throat exposure: unknown clinically resolved
Patient reported vomiting the night of vaccination, and nausea the next day, as well as the usual pain /tenderness in arm of the pneumonia shot (the left).
7 days of Dizziness, chest and lungs burning sensation and pain (very strong)  fatigue.  I had fever 103, headache and shaking chills  on the first and second day (I think this is normal) I am worried about my lungs and chest.
Normal side effects: sore arm, headache, stomach pain which went away within 3 days One week after injection (12-17-20) I developed a small patch of painful rash on my forehead near the hairline.
Case number PHEH2014US004177 is an initial spontaneous report received from a nurse on 26 FEB 2014 with a follow up report received from the nurse on 24 MAR 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly on 15 JAN 2014. No adverse event was reported following this administration error. No seriousness criteria were ticked.     Non significant follow up report received from the nurse on 24 MAR 2014: Updated patient demographics (height and weight).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Patient has soreness and a rash at the injection site. She is taking Ibuprofen for the soreness which is helping. I told her to use BENADRYL cr on the rash.
redness going lower down to the arm to elbow; pain in night time; it was sore; very hard; injection site became red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red) had resolved.            Concomitant Medication includes Blood pressure  and Cholesterol Medication  Treatment Medication includes : Cold Compressive  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant followup received on 17-Jun-2021. Event outcome details updated.
Post vax, the child complained of dizziness, limp-eased to the floor, body jerked and became rigid; then arched back and then sat up and was unaware of what happened.
It felt like fire on the inside of my arm as soon as the medicine was injected. It was hot to the touch within minutes of me getting the injection and I immediately broke out in hives. I reported it to office manager and took puctures. my treatment was me taking Benedryl.
top of right thigh-red, swollen, screaming/pain, lasted 1-2 hrs after treatment w/ Tylenol and warm compresses. Fever x 48hr.