chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was a 4 y.o. previously healthy female with PMHx sig for ex-32 weeker twin who went to NICU and had a grade I IVH at birth. She presents as a step-down from the PICU secondary to febrile seizure after receiving MMR and Kinrix vaccines who developed aspiration pneumonia and needed to be intubated in the ER secondary to apnea, extubated 2 hours later. She had a Tmax of 39.2 at the OSH and a Tlast of 38.5 today at 04:26, but is currently afebrile at 36.6. Mom says the child received her 4 y.o. vaccines (MMR, IPV, DTAP) yesterday AM at her PMD's office, and went to daycare afterwards. She picked the child up from daycare at approx 5:45 pm, and while in the car, the pt stopped moving and was fixated to her right side. 911 was immediately called. The pt then began to have a tonic-clonic seizure that lasted >20 minutes witnessed. Per mom she did not defecate or urinate during seizure. She received 2 g of Ativan in the ER. She then became apneic and was intubated. She was then transferred to another hospital PICU. She was found to have an upper lobe aspiration PNA and was treated with Clindamycin and Ceftriaxone, Day 1/2. Blood, urine, and CSF cultures have been obtained and we will follow these results. Neurology, was consulted and a spot EEG was normal. She was discharged the following day a with normal neuro exam.
Red bump right thigh at site of vaccine. Painful. Gradually increased in size. Treated as cellulitis 11-16-17 KEFLEX.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as 6359660. No concomitant drug was reported. No treatment drug was reported.
Mild swelling, redness, discomfort at a region on the patients left arm adjacent to the vaccine administration site.
Symptoms included extreme lethargy, headache, body aches, loss of appetite, night sweats, shortness of breathe.  Symptoms stared on 4/26 (almost 3 weeks after Janssen 1 dose injection) and increasingly got worse over 5 days.  I took the 'rapid results  COVID test  and it came back positive.  Symptoms continued (although lessened) for 7-10 days after testing positive.
Constant Moderate to Severe Tinnitus in left ear Intermittent Moderate Tinnitus in right ear
Near immediate swelling, and some itchiness throughout body. Face most severe, lips swelled so they didn?t quite meet. Tongue felt huge. Eyes swollen puffy. Throat scratchy, sore. Stomach upset, also felt kind of scratchy, hard to describe. As it worsened slight dizziness faintish feeling,  Pharmacist prepped  epinephren but started with anti-histamine, drank lots of water. Swelling gradually slowed. Remained nearby for observation for approximately two hours following vaccination. Symptoms gradually decreased,  took more antihistamine at few hours as still feeling mild symptoms
1425 Pt recv Pfizer booster. within 14 min pt stated the she was starting to have trouble swallowing. that she felt lightheaded, throat felt tight and has and increase of saliva. Pt stated her initial vaccine series was with Moderna and she had the same reaction and recv Benadryl. Pt stages she decided to recv Pfizer booster in order to avoid a repeat reaction. Pt was taken to the triage area and vital signs were taken. MD called to access pt and admin Benadryl 25mg po. Symptoms resolved within 15mins. VSS, pt was discharged to home with no further intervention.
The day after I received my moderna booster shot, I became extremely dizzy and could not stay sitting up without getting vertigo. Vertigo. My arm has a swollen lump in a circular form and it looks very much like a bullseye. Headache was also part of it
Chest tightness, wheezing, cough, SOB. Onset 1degree after admin with s/s worsening as day progressed. Tx: nebulizer tx with ALBUTEROL
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had not received any other medication in 2weeks. Patient had received Paxlovid as COVID 19 Treatment from 31Aug2022 to 05Sep2022. Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported events DRUG INEFFECTIVE and Covid 19 are assessed as related to suspect drug .
About 1 hour after vaccine: Strange taste in mouth, strange feeling on tongue (not swollen)  About 24 hours after vaccine: itchy face, headache, stiff neck and back, fatigue, low fever   After 40 hours: fever gone (highest was 99.8), stiff neck and back improving, fatigue improving, face is still itchy.
Had a fever, chills, sweats, sore for three days. I have had significant shortness of breath ever since.
Contracted Shingles on face and head 10 days after receiving 2 shingles shot.
Deathly sick; Back ache; Vomiting; Nausea; Pain; Sweats; Feels cloudy; Weak and tired; Weak and tired; Pain in back on left side, cannot walk; This is a spontaneous report received from contactable reporter(s) (Other HCP: Registered Nurse) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Dec2021 12:30 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date Nov2021 (Batch/Lot number: unknown) as single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Deathly sick"; BACK PAIN (non-serious), outcome "unknown", described as "Back ache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweats"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels cloudy"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Weak and tired"; GAIT INABILITY (non-serious), outcome "unknown", described as "Pain in back on left side, cannot walk". Therapeutic measures were not taken as a result of illness, back pain, vomiting, nausea, pain, hyperhidrosis, feeling abnormal, asthenia, fatigue, gait inability. The lot number for bnt162b2 was not provided and will be requested during follow up.
Vx is so painful, liquid seems to stay; Not able to sleep because of pain; Got arm  Paralyzed; fever; This case was reported by a consumer via interactive digital media and described the occurrence of arm paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got them two weeks ago prior to first dose).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm paralysis (serious criteria GSK medically significant), pain, fever and difficulty sleeping. On an unknown date, the outcome of the arm paralysis and fever were recovered/resolved and the outcome of the pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the arm paralysis, pain, fever and difficulty sleeping to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the first dose of Shingles vaccine and got the arm paralyzed for three days and got two days of fever.  When the liquid was coming in seems that it was staying there, the vaccine was so painful that you could not sleep because of the pain. The patient will get the second dose on 17th March 2023. No contact details available.  Additional supportive information: The follow-up could not be possible as no contact details were available.
Narrative:  COVID infection following COVID vaccine series 01/18, Pfizer,  dose #1 02/09, Pfizer, dose #2 08/31 COVID swab, result: detected 08/31 SARS- COV-2 Variant Sequencing result: 08/29 pt cc: cough chills, fatigue, headache,  rhinorrhea exposure: unknown
Swollen lymph nodes; pain radiating down arm injected, shoulder area & chest; pain and itchiness at injection site; sharp fleeting pains throughout body; chills; twitching eye; fatigue; headache
Diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/Rash continued to spread, right leg; Diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/Rash continued to spread, right leg; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; lot number: EL9269and expiration date was not reported) via an unspecified route of administration in the left arm on 15Feb2021 09:45 (at the age of 65-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension and fibromyalgia. Concomitant medication included atenolol, simvastatin and diphenhydramine Hydrochloride, all for an unknown indication. The patient had history of erythromycin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. After taking the first dose of vaccination, on an unspecified date of Feb2021 the patient experienced diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/rash continued to spread, right leg. Patient was not tested positive for COVID-19 since the vaccination. Therapeutic measures in response to the events included, topical and oral steroids. The outcome of the events was not resolved at the time of report.    Follow-up attempts are completed. No further information is expected.
I don't have my menstrual period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I don't have my menstrual period".  Additional Information: Forwarded as an Adverse Event by the team on 28Mar2022 Reporter provided verification of contact address on 26Mar2022.Patient reported that she received her three doses of covid 19. After her third dose she did not have her menstrual period. And she was not pregnant. Her daughter received the third dose and she has the same problem and she was not sexual active. She was not pregnant she was virgin.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tinnitus,  headache/pressure,  facial nerve/muscle issues (twitching, vibration feeling, numbness)
Localized rash at injection site on left deltoid with 4 to 5 maculopapular pruritic lesions.  Tender to palpation.  Lesions grew slowly larger and itchier.
TOTAL BODY RASH-WITHIN 10 MINUTES. GETS FLU SHOT EVERY YEAR NO PROBLEM THIS YEAR GOT QUADRAVALENT.
ACTHIB was reconstituted with an incorrect diluent (with no reported adverse event); product had expired on 13AUG2023 (with no reported adverse event); Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 14-month-old female patient for whom administered expired HIB (PRP/T) vaccine [ACT-HIB] which was reconstituted with an incorrect diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 05-Sep-2023, the patient received an expired dose of 0.5 ml 1x (frequency: once) suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength (lot: UJ803AA, Expiry date: 13-Aug-2023) via intramuscular route in the left thigh for Immunization which was reconstituted with an incorrect diluent with no reported adverse event (expired product administered)  (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the 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.
by 930PM 30APR92 t104.4 w/Advil & APAP; mom took to Er was limp & out of it; tx exam & WBC dx rxn to pertussis;
Initial report was received from a consumer, who was also the patient's parent, on 16 June 2013. This reporter reported another adverse event for the same patient which was captured in case number 2013-07003. A female patient had received an injection of HIB VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later had a seizure. No other information was available. Outcome was not reported. Documents held by sender: None.
Day 1:  arm soreness, headache, dizziness, chills, diarrhea, fatigue, muscle aches, overall sick feeling (took Tylenol consistently & slept a lot) Day 2:  arm soreness, armpit lymph node pain, headache, dizziness, chills, diarrhea, fatigue, muscle aches, overall sick feeling (took Tylenol consistently & slept a lot) Day 3:  arm soreness, armpit lymph node pain, headache, dizziness, diarrhea, fatigue, heaviness on chest, overall sick feeling (took Tylenol consistently & slept a lot) Day 4:  arm soreness, armpit lymph node pain, headache, dizziness, diarrhea, fatigue, heart fluttering, low blood pressure and pulse for me overall sick feeling (took Tylenol consistently & slept a lot) Day 5:  arm soreness, armpit lymph node pain, headache, dizziness, fatigue, heart fluttering, low blood pressure and pulse for me overall sick feeling (took Tylenol consistently & slept a lot); also called hospital to discuss symptoms and was told that this isn't normal so I had to complete this form along with an internal adverse event form - if symptoms worsen they said that I should go to urgent care otherwise keep doing what I'm doing
26 days after 1st Moderna vaccine patient developed shortness of breath.  Patient ended up having a positive d-dimer. CT scan done the following week showed severe bilateral pulmonary emboli in all lobes of both lungs.
I developed skin sensitivity, pain and rash. Doctor confirmed shingles and started on antivirals.
Left side of face became paralyzed 10-16-09 tongue became numbed on 10-14-09 - went to ER on 10-16-09. CT done WNL; Prednisone and Acyclovir given 10-16-09 to be taken 10 days.
Redness, swelling and itching of left deltoid, where he was given the injection. Was very itchy and red the night before he came into the clinic. When he presented to the clinic Friday morning there was no itching and only mild redness and swelling the are did feel hot to the touch. Advised to ice the area and given hydrocortisone cream to put on the site.
Individual recipient was given a first dose of Pfizer at medical facility on 4/13/21.  Recipient answered the questionnaire  NO.  On  4/17/21, wife of the recipient reported that recipient already received the first dose of Moderna on 3/24/21 at the Recipient has not reported any adverse event.  MD has been made aware.
Received HBV #3 on 2/5/04. No reaction until 2/6/04 when he noticed redness around injection site, on 2/8/04 became diaphoretic and experienced perfuse itching which lasted about 1 hour. No treatment reported to clinic on 8/9/04 9AM.
swilling in right arm at vaccination site, started that day and has continued upon inspection at second dose 28 days later (02/26/21)  injected second dose into left arm.  Swelling if right arm is visible at deltoid muscle.  also has got shingles rash soon after immunization.
The day after I got the vaccine I began having headaches. Severe joint pain and stomach cramps. They continue to this day.
Patient received 2nd dose of the Moderna COVID vaccine 21 days from the 1st dose instead of 28 or later as recommended.  Dose 1 administered on 9/17/2022 Dose 2 administered on 10/08/2022
Patient monitored in the office after influenza vaccination due to to previous episodes of facial and arm numbness following influenza vaccination. Approximate 30 minutes after influenza vaccination IM, patient developed numbness of the left face, left side of neck and left shoulder extending to her left elbow. There is no weakness, slurred speech, dysarthria, diplopia, no leg numbness.  Symptoms remain stable for an additional 1.5 hours of monitoring. There was no dyspnea, lip, tongue, throat swelling. Lungs were clear to auscultation and percussion. Respirations unlabored.  No leg edema, cyanosis, or clubbing. Patient was discharged with no intervention given.
lump in her arm; redness; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Concomitant medicines like Lexapro and second concomitant which name was not clear.
Brachial plexitis in LUE pain / burning redness swelling radiating to post Arm
Sore, red and a little swollen at injection site. Ice 10-15 minutes 3-4 times daily, Motrin, HC cream.
cellulitis at the injection site; redness, and flaky skin at the injection site; flaky skin at the injection site; patient never received the second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2021, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: cellulitis at the injection site), injection site erythema (Verbatim: redness, and flaky skin at the injection site), injection site exfoliation (Verbatim: flaky skin at the injection site) and incomplete course of vaccination (Verbatim: patient never received the second dose of Shingrix). The outcome of the injection site cellulitis, injection site erythema and injection site exfoliation were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema and injection site exfoliation to be related to Shingrix.   It was unknown if the company considered the injection site cellulitis, injection site erythema and injection site exfoliation to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter reported that one of his customers received her Shingrix. The reporter reported that the patient never received the second dose of Shingrix (Inappropriate Schedule of Vaccine).  The reporter reported that the patient experienced cellulitis, redness, and flaky skin at the injection site. (no other details were known).  Lot number was not known.  The reporter wanted to know the likelihood of this same type of above reactions to the Arexvy Vaccine. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Approx 4 hrs post vax pt had unconsolable crying, very intense for 20min but episode lasted about an hr;