chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONSUMER RECEIVED 1ML DOSE OF VACCINE; OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) 1 ml, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced consumer received 1ml dose of vaccine. On 22-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the consumer received 1ml dose of vaccine and off label use was not reported. This report was non-serious.
a lot of itching; very weird hardness, hardness is getting bigger than it was; pain in her arm; swelling in the injection site; itching is like a mosquito bite; headache; joint pain; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site) and RASH PRURITIC (itching is like a mosquito bite) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient do not have any allergies.The patient had never been diagnosed with/ tested positive for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (first 3 vaccines were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS (unknown Hypo or hyper).    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, VACCINATION SITE PRURITUS (a lot of itching), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown and VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was) had not resolved.            Concomitant products included High Blood Pressure medication and Thyroid medication.  Patient received fourth dose of Moderna vaccine on 13-APR-2022.
Johnson and Johnson covid vaccine given after 1st dose of Pfizer vaccine.  Patient was immediately advised of error and completely informed of same.  She was assured that she would be fully vaccinated nonetheless .  The clinic will follow up with a call . No complications were noted after 30 min observation
About a week after vaccination I started to feel a tingling, burning, almost itching feeling in my thighs and calves. It is not very uncomfortable but very noticeable.
-Fever of up to 102 for 36 hours (alternated Tylenol and ibuprofen)  -Intermittent chest pain for 8 days at rest after minimal or no exertion -Tachycardia at rest and exertion with medication for 36 hours  -Intermittent multiple Headaches  daily with minimal exertion or movement for 8 days that would last a few minutes with medication  was not effective only no exertion (rest). -Currently will have random headaches with minimal exertion or movement that is relieved within minutes with rest, multiple times a week.  -Sharp stabbing and burning sensation in my left arm in the area of the injection site from my first vaccine multiple times a week. The first time experienced was approximately 10 minutes after vaccine.
Patient is a 9 yo boy history of premature birth, otherwise previously well, now admitted with febrile illness associated with abdominal pain, vomiting and diarrhea, and with elevated inflammatory markers, suspected MIS-C.  On 12/16 he developed headache.  He was otherwise well, though the following day he again had headache, and developed abdominal pain and body aches.  Symptoms worsened on 12/18 and he developed fever.  12/19 he was seen by PMD with worsening symptoms.  Rapid strep, COVID, and flu all negative.  The following day he developed higher fever, worse abdominal pain and body aches, and developed profuse watery diarrhea and persistent emesis with any PO intake.  Returned to PMD on 12/21 (yesterday). Repeat rapid strep positive, COVID negative.  Referred to ER for evaluation.  He has not been able to tolerate PO intake since start of emesis on 12/20.  He has had a dramatic decrease in activity and remains very listless.  He has not had significant cough or congestion.  He is noted to have swollen eyes with conjunctival injection today.  He has been complaining of a sensation of fullness in his throat described as "lumps".  No noted adenopathy.  Although he is achy all over, the pain is most intense left side of neck.  His urine looks darker today.  A few weeks ago he did have a single dry patch of skin on one leg.  That has since resolved with a moisturizer.  No other rash.  No extremity swelling.  He has not had a recent febrile illness.  He does say his taste is off during the current illness, though no prior loss of taste or smell.  He has had intermittent URI symptoms over the past few months, though nothing out of the ordinary.  All systems negative other than as noted.  His parents had COVID early in the pandemic in February and March of 2020.  His sister who lives with the family had COVID in 9/2021.  Patient was negative at the time.  His parents do note that they receive notice from the school regularly that there have been COVID cases.  Patient is in-person school.   In the ER yesterday he was febrile and tachycardic.  Labs with left shift on WBC, lymphopenia, borderline low platelets, markedly elevated CRP.  Urinalysis had mild pyuria and hematuria, negative LE and nitrite.  COVID antibody was positive, PCR negative.  CTA showed appendicolith but no acute abnormality.  Admitted inpatient on ceftriaxone.  Ferritin and D-dimer added today markedly elevated.  BNP and troponin normal.   PMH - Born at 27 weeks gestation.  He was followed by cardiology and ophthalmology for the first year of his life, but has since been cleared by both services.  Otherwise previously well. Allergies - NKDA Immunizations UTD including dose 1 of COVID on 12/3.
Swelling of arm from shoulder to elbow, hives, nausea, fever 101
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a seven years old patient and reported that 7 years old was too old for DAPTACEL, but not old enough for ADACEL, while he/she received vaccines IPOL, QUADRACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR; and VARICELLA ZOSTER VACCINE. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 22-May-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5248AA) (Expiry date and dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event was reported. 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. List of documents held by sender: none.
Red, raised, hot, painful to touch. Site injection that is enlarged and growing, The site measures 4 inches x 3 inches. Patient has taken Benadryl without relief or symptoms. the area is marked and she is advised to continue Benadryl and contact office if the symptoms worsen or do not improve.
No additional AEs were reported; Nurse reported that an expired VAQTA was given to a patient.  No additional AEs were reported, No further information provided.  No PQC.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 23-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection at a dose of 0.5 milliliter (ml) once as prophylaxis (lot number u012007 has been verified to be valid; expiration date reported and established as 18-JAN-2023) (expired product administered) (strength, route of administration, and anatomical location were not provided). No adverse effects were reported.
Vertigo, lightheadedness, dizziness persisting over 24h. Associated headache initially
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06May2022 at 13:00 as dose 4, (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "DMII" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "palpitations" (unspecified if ongoing). "Known allergies: Aldactone, Wellbutrin, morphine causes vomiting" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATENOLOL; PIOGLITAZONE; FLUOXETINE; JARDIANCE; LOSARTAN POTASSIUM; ATORVASTATIN; LORATADINE; B12 [CYANOCOBALAMIN]; D3; BYDUREON BCISE. Past drug history included: Morphine, reaction(s): "morphine causes vomiting", notes: morphine causes vomiting. The following information was reported: COVID-19 (medically significant) with onset 13May2022 at 12:00, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 13May2022 at 12:00, outcome "unknown". Therapeutic measures were taken as a result of covid-19 with Paxlovid (Lot: FY6859) on 12May2022.  No follow-up attempts are needed. No further information is expected.
Pt cried for 4 hours with stopping, after immunizations given 3/3/03. Grandmother stated "head got swollen too". Reported to me 6/20/03. Went to ER but left before seen due to pt stopping crying.
This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patient's medical history, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) orally, (dose, anatomical location, lot number and expiration date were not reported). There was not concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
On 4/17/2021, started to get a sore throat (hurt to swallow anything).  Felt the lymph nodes on the right side of my neck and noticed they were swollen.
A report has ben received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter stated that the patient was administration of expired dose which started on 09-sep-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
The patient reported arm pain after 3 weeks from the date of the shot. She complained that her arm ached after reaching for the door.
BOOSTRIX side effect: Very swollen testicles and groin lymph nodes, accompanied by severe pain and nausea in my 12yr old.
Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; BP is still get down; Soreness in all of my joints and muscles; Soreness in all of my joints and muscles; 101 fever; Shivering; Arm got very sore; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22May2021 10:00 am as DOSE 1, SINGLE for covid-19 immunisation (at the age of 59-Years). Medical history included asthma, blood cholesterol increased, have a hole in her heart, COVID before in Jan (unspecified) and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity, cetirizine hydrochloride (ZYRTEC ALLERGY, atorvastatin calcium (LIPITOR) taken for blood cholesterol increased, carvedilol (COREG) taken for cardiac disorder, all from unknown start and stop date were not reported. Patient had her first Pfizer dose (Unspecified vaccine) on 22May2021 Saturday morning and her arm got very sore immediately and around like 9 in the evening she started feeling very soreness in all of her joints and muscles, at about on 23May2021 1:30 in the morning she woke up with 101 fever and she was shivering, and she had COVID before in January, it felt like she had COVID again, the trembles the shaking and the tiredness and the weakness. And she thought this wasn't supposed to happen until they get the seconds shot. So she was a little nervous about getting the second shot and she want to know if what she had experienced with the first shot was normal, was the normal side effect for the first shot, she mean she was still very weak, she was like laying down all yesterday. She iced her arm where the shot was given and taken Tylenol, the fever went away yesterday morning, not yesterday morning like yesterday afternoon. So, she just want to make sure that she was safe for the second round or will the first shot be enough since she had COVID before. She stated that she just wanted to make sure because she don't know if she should go for the second shot or not and if this was normal because everybody was tell her what the side effects were now (not clear). The outcome of the events fatigue n and blood pressure decreased was not recovered, event pyrexia was recovered, and outcome of other events was unknown.
Looks like small hives; Rash all over my sides, stomach, too potion of thighs. Started about a week and a half after my last dose. Started out on my right rib cage and then moved through rest over the next week.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in Apr2021 (Lot Number: Ep7533) at the age of 40 years as single dose for Covid-19 immunization. Medical history included hyperthyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of BNT162B2 (lot number: Er8735) administered in left arm on 31Mar2021 at the age of 40 years as single dose for Covid-19 immunization. Patient was not pregnant. There was no other vaccine in four weeks, no Covid prior vaccination, no known allergies. Patient experienced rash all over her sides, stomach, too potion of thighs. Started on 01May2021 04:00 PM, about a week and a half after her last dose. Started out on her right rib cage and then moved through rest over the next week. Went to care spot where they couldn't make any connection to things and gave her an oral steroid to take daily for a week, which didn't help. Ae resulted in doctor or other healthcare professional office/clinic visit. No Covid was tested post vaccination. Outcome of events was not recovered.
LOCAL RXN - IMMUN SITE RED W/A RED RING BORDER APPROX 1 INCH AROUND SHOT SITE; UPON PALPATION, A DEEP-HARD NODULE WAS FELT. NO OTHER S/S. NO TX INITIATED. MD WAS GOING TO LOOK AT TODAY.
Pt recvd a 3rd dose of Engerix-B on 16MAY91 & 4th hrs later exp pain in rt arm, swelling, discoloration, t102, abscess, bruising; Pt missed 7 working days, 60 hrs due to rxn; PCN, pain meds, ice & heat were used to treat the events;
Breakthrough case admission after 2 vaccines Pfizer 5/21/21 lot# EW0182;  Pfizer 6/11/21 lot# Ew0180
1 week following the first Moderna injection, the injection site became itchy, red, and swollen. It was tender and painful to the touch. The reaction lasted about 1-2 full days and was fully cleared up by 1/21. I contacted my doctor via telephone on the morning of 1/19 and was relayed a message that the side effects were normal and I shouldn't be concerned. I asked to speak directly to my doctor, which I finally did on 1/21, and by that time the reaction has cleared up.
Information has been received from a pharmacist concerning a 47 year old patient who was to be vaccinated with varicella virus vaccine live (MSD), but inadvertently received zoster vaccine live (Oka/Merck). The patient did not experience any known symptoms. Unspecified medical attention was sought, the patient contacted the Pharmacist. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. There were no drug reactions/allergies or pertinent medical history. The patient was vaccinated with the first dose of GARDASIL injection (lot# H020901, expired date: 05-JUL-2015, dose and route unspecified) on an unspecified date "a couple of months ago". There was no concomitant therapy. The patient returned to the reporter's office at a later time on the same unspecified date complaining of "severe ear pain, headache, jaw pain, fever and myalgia". The patient was treated with "ear drops for pain, an antibiotic and MOTRIN". The patient had not received any further doses of GARDASIL at that time. The outcome of adverse events was reported as recovered on an unspecified date. The relationship between adverse events and GARDASIL was not reported. Additional information has been requested.
Next day after receiving 2nd moderna vaccine  pt felt weak and visual changes. Third day after extremity weakness. Confirm acute ischemic stroke
Patient reported muscle pain at the left arm, where immunization was administered, after few months. Arm feels very weak, and something wrong w/ rotating cuff, pt claimed, told pt to have MD check.
Spasm in the back of neck; difficult to sleep; This is a spontaneous report from a contactable consumer (reporting for himself). A 71-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on his left arm from 29Jan2021 11:40 to 29Jan2021 11:40 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included cholesterol, gout, vitamin supplementation, and hypothyroid. Concomitant medication included simvastatin for cholesterol, allopurinol for gout, cinacalcet for hypothyroid. On 30Jan2021, the patient has a spasm in the back of his neck that makes it difficult to sleep and if you turn your head in any direction, you get a crook in your neck and it feels like someone is grabbing you by the back of neck. Therapeutic measures were taken as a result of spasm in the back of neck which included Tylenol Arthritis pain. The outcome of the events was not recovered.
Red upper left thigh swollen, warm to touch. Rx: Atarax (10mg/5ml) 5ml tidX5d
Seizure (generalized tonic, clonic) within 24 hours after administration of vaccine.
fever - shivered all night; ached all over, headache, dizziness the next morning. Lasting 2.5 days
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles). At the time of the report, BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Pt vaccinated with MMR developed temp of 103 x 2 days, joint stiffness & soreness lasting several days, dry cough & headache, broke out in a rash, site of injection red & localized warmth. Rash subsiding.
Maculopapular rash with itching across upper anterior chest wall and upper abdomen starting after vaccination and continuing to present day.
0811 - pt c/o lightheaded and flushing.  Pt reports I feel like I am going to pass out.  Pt assisted to stretcher.  BP - 131/83, hr 87, rr 22, sats 100. Pt given water. 0813 - Pt reports "I am feeling normal.:  0814 - 120/79, p 74, rr  20, sats 99 0818 - Pt clearing throat.  Pt states this happened with first vaccine.  Pt states "I feel a tickle in my throat."  Pt unable to take Benadryl pills. 0820 - Pt given 25 mg liquid Benadryl 0828 - bp 137/85, hr 67, rr 18, sats 98.. Pt reports I feel better.  Pt assisted to chair. 0835 - Walked in hallway with patient.  Pt reports I feel normal. 0840 - Pt walked to door.  Denies throat tickle, being lightheaded or flushed.