chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full body muscle tenseness; This spontaneous case from was received on 04-Nov-2020 from pharmacist via Agency (reference number: SEQW20-04773) and concerned a 71-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 279819 and expiry date was 30-Jun-2021.  On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed full body muscle tenseness.  At the time of initial reporting on 04-Nov-2020, the patient had not recovered from the event.  The reporter did not provide a causality assessment to Fluad Quadrivalent.  The reporter assessed the event as non-serious.  Company comment: A 71-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced full body muscle tenseness. More information regarding medical history, concomitant medications and temporal relationship is needed. With information available, causal role of the suspect vaccine is assessed as possibly.; Sender's Comments: A 71-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced full body muscle tenseness. More information regarding medical history, concomitant medications and temporal relationship is needed. With information available, causal role of the suspect vaccine is assessed as possibly.
Patient received first dose of Moderna COVID-19 vaccine on 4/21/21 and was scheduled to receive second dose on 5/19/21; patient instead received second dose of the Moderna COVID-19 vaccine on 5/22/21 (8 days early).
fever; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021 02:15, the patient received Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix vaccine and had a slight fever last night. The follow up would not be possible as no contact details were available.
Headache, malaise, fatigue occurred approximately 24 hours after second dose. No treatment, symptoms resolved in less than one day.
Headache, joint pain, fatigue, excessive sleep, loss of appetite, fever 101 F.
Was anxious after - then tired/fatigue- wheezing. Taken by ambulance (911) to ER. Released. ORAPRED, CAREDIN.
Injection site lump; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INJECTION SITE MASS (Injection site lump) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INJECTION SITE MASS (Injection site lump). At the time of the report, COVID-19 (COVID-19) was resolving and INJECTION SITE MASS (Injection site lump) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
1/20/21 @11:00 am=Received 2nd dose of Moderna vaccine 1/21/21 @03:00 am=chills, headache, vaccine arm sore, bodyaches lasted for less than an hour 1/21-22/21= above symptoms resolved 1/23/21 @1:40pm=tachycardia around 130's bpm while talking /walking a few steps at work for about 3 minutes                                              (normal resting HR=high 60'sto mid 70's) 1/23/21 @2:00pm -7:00pm= on and off tachycardia with HR between 90's to 120's at rest, checked in at hospital, IV hydration, all work up (EKG, troponins, BNP, CT angio, bloodwork) NORMAL.....discharged home 1/24-28/21 = fatigue. recurring tachycardia but HR only in low 100's with walking
After I left the center as I was driving home I couldn't swallow. I took a sip of water and started to choke. I pulled in to the parking lot if the fire dept to see if it went away. I waited for about 5 more minutes and then I could swallow again.
My period was delayed in starting/started about 7 days late and then I had menstrual bleeding for 18 days that was very heavy. This is very irregular for me.   I did also have a fever of 102.9, myalgias, chills, and joint pain on 3/31-4/1/21 right after receiving the vaccine
Kinrix was the vaccine applied and Boostrix didn´t; Kinrix was the vaccine applied and Boostrix didn´t; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Kinrix and an unknown time after starting Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 provided as follows: The age at the vaccination was not reported, however the patient could be 8 years or 9 years old at the time of vaccination. A health care provider informed that a  Patient received a Kinrix dose instead of Boostrix at an inappropriate age and wanted information to proceed in immunization against DTAP-IPV, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked to US2021129069; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129069:same reporter
Patient received immunizations on Monday, called Tuesday about redness and pain in her arm, came in to pharmacy on Wednesday arm was red and swollen from injection site to elbow and warm to touch.  Patient was advised by pharmacist on duty to go to her primary care doctor (appeared to present as cellulitis).  Patient returned to pharmacy an hour later with a prescription for Bactrim DS, 1 tablet po BID for 7 days.  Patient returned to pharmacy Thursday to show the pharmacist on duty that her swelling and redness had decreased.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/11/21 2nd dose02/08/21 Diagnosed covid positive:09/16/21 Symptom onset:09/15/21 Exposure: Symptoms:fever, cough,runnynose
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for COVID-19 immunization; 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), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Glaucoma in left eye only. Concomitant medication(s) included: COMBIGAN, start date: Jan2008; DORZOLOMIDE HYDROCHLORIDE, start date: Jan2008; TRAVOPROST, start date: Jan2008; RHOPRESSA, start date: Jan2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Clinical course: Treatment start date: 07Dec2022, Treatment stop date: 11Dec2022,Completed course of Paxlovid on 11Dec. Tested positive for COVID on 14Dec. Return of cough on 15Dec. Return of sore throat and runny nose on 16Dec (today). Adverse event start date: 14Dec2022, Adverse event start time: 08: 00 AM,Device timestamp: 16Dec2022  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
no addtional AE; products experienced an excursion had been administered to patient; This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to a 4-year old patient of unknown gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.    Per reporter, varicella virus vaccine live (oka/merck) (VARIVAX) with lot# U015682, U002394, and U010400 experienced an excursion of minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 07-SEP-2021 during transport and minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 09-SEP-2021 during transport. On 09-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U015682, expiration date 18-MAY-2023, dose: 1 (unit unknown); strength and route were unknown) for prophylaxis (product storage error). Previous temperature excursion of this vaccine was reported as minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 7 hours and 30 minutes. No additional adverse event reported.  This is one of several reports received from same reporter. ; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005632: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005758: US-009507513-2109USA005648: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005639: US-009507513-2109USA005662: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005618: US-009507513-2109USA005881: US-009507513-2109USA005902:
Patient history of multiple allergies s/p COVID infection 5/2021, seeing allergist, who considered risks vs benefits and recommended patient receive the COVID vaccine.   Patient given Janssen COVID vaccine on 9/16/21 at approximately 12:20PM.  During 15 minute observation period, patient experienced "impending doom", starting breathing fast and felt nauseous. Was pacing to "try to prevent vaccine reaction".  Reported left arm itching "feels like it is on fire" and difficulty breathing.   1227: BP 164/92, O2 99, HR 154, lungs CTA, reports dizziness and near syncope, hyperventilation 1231: placed in wheelchair and taken to an exam room Patient reported throat "tightness", nausea, labored breathing, pressured speech, dry heaving.  Airway clear, no swelling noted. 1231: Benadryl 50mg IM administered R deltoid 1234: BP 155/100, O2 99, HR137 1235: 0.3mg Epinephrine administered Left thigh, EMS called 1236: BP 145/94, O2 99, HR 128-144 1237: HR 152 1239: BP 140/78, O2 99, HR 148 1240: Family Notified 1244: Patient transported to Emergency Department via EMS, patient breathing improved, teeth chattering and body tremors noted  EMS: Zofran and duoneb administered.   Hospital report: VSS, monitored for 4 hours, Atarax administered for itching, Ativan given for anxiety. NSR, discharged.     9/17/21- Patient called for follow-up, reports continued headache, fever, body aches, itching, tacycardia (115) 9/20/21- Patient called for follow-up, symptoms improved, does report random facial twitching
Fatigue; Fever - Temperature of 101.8F; Head Ache; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm Pain), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 14-Feb-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache). On 18-Jan-2021, PAIN IN EXTREMITY (Arm Pain) had resolved. On 18-Feb-2021, FATIGUE (Fatigue), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient was given MMRV instead of regular MMR, n addition to Varicella vaccine. Resulting in a mega dose of Varicella.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 to 5 years before the date of reporting). On 24th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 24th April 2018, the patient experienced headache. On 25th April 2018, the patient experienced injection site swelling, injection site pain, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives. On an unknown date, the outcome of the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives were recovered/resolved. It was unknown if the reporter considered the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient received SHINGRIX into the left arm. The patient stated that, the next day after vaccination, the area of the injection was red and then she noted 3 little hive looking spots that turned into swelling in the area; they went away over the 2nd week. The patient stated that, the first week she felt bad but gradually got better. The patient had discussed the events with her physician, as she was concerned about getting the 2nd dose. Her physician only voiced allergic reaction concern of that noted in the prescribing information of anaphylaxis, which the consumer had denied. The patient stated that the general events lasted for about a week. The side effects from the clinical trials were discussed. The healthcare professional was not asked.
pt recv vax & 2 days post vax devel hives & itching;this is one of 4 patients from this site who exp above rxn;
Client stated she Received vaccine 1:30 pm on Monday. Experienced the usual pain at the time of injection. No fever or dyspnea. Pain and soreness increased and became intolerable (10+ pain scale 1-10) radiating to neck and along arm with tingling and numbness in fingers. Called a nurse was told to go to ED immediately to R/O possible MI. Client went around 6AM to hospital ED. Sent home with VICODIN q4-6 hours. Client state there has been no improvement and no relief from pain. Went to primary care provider Dr. Referred to ED. Given TORADOL, ZOFRAN, Hydrocodone 600-mg ibuprofen for home. Still no improvement over the weekend although states that she is now able to move fingers and grab someone's finger, no tingling and numbness since Saturday and can bend at the elbow but cannot lift, abduct or adduct arm. Is trying to follow up with neurologist unable to get appointment today.
Started out with a slight head ache that night.  Next morning felt terrible, had fever, chills and head ache.
started chills & shaking felt cold & queasy; wrapped up warm went to bed @ 930PM; awoke @ 8AM took med, felt nl @ noon time;
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 25-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 12-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
3.5cm induration possible abscess;3cm erythema on cefzil;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 05-JAN-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-SEP-2014, the patient was treated by a physician (site not specified) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Fever, poor feeding x1, hospitalization and sepsis work up. 01/28/2008 Hib Lot # confirmed 0820U. 02/01/2008 MR received from CDC for DOS 1/27-29/2008 with D/C DX:  Fever post-immunization. Infant presented to ER with fever, decresed activity, and decreased po intake. PE WNL except temp 101.3'F. Pt had received recalled Pedvax HIB vaccine. Admitted for sepsis w/u. Txd with abx. Afebrile remainder of hospital stay. Per 60 day follow up: Patient most likely had an incidental viral infection at the time of vaccination.
episode of near syncope and diaphoresis, drop in BP followed by chest and neck pain lasting about 1 hour
Not long after receiving the vaccine I experience myocarditis symptoms, tingling in all my fingers and toes, swelling in my left forearm (about mid way between my elbow and wrist).  These symptoms lasted from 3 to 5 days (approximately).  I did not seek treatment because I live in a rural area.  Driving myself to the hospital was not an option.  Ambulatory is not an option due to expense & I didn't (at the time) think I would be able to be saved, honestly thought I would die before an ambulance got to my house.  Then the pounding in my heart subsided, then it  came back, and subsided, so I figured I would be okay & didn't go to the doctor.  I am still having odd heart area types of feelings - no more pounding, more just minor chest pains and sometimes fluttering feelings.  A symptom I have noticed and lately thought that could be related - I had allergies before (seasonal), I am being tested for allergies to what might be in the vaccination, because I am seeking a medical exemption from getting the second shot.  I have an inordinate amount of allergies, that I never had before August (not just seasonal).  My allergic reactions are beyond anything I've ever experienced, for at least the last 4 months.  It might have started right after the injection, but I might have written it off to being my regular allergies (at the time).  My seasonal allergies never really bothered me in Nov, Dec, Jan before - but they have been constant and extreme the whole winter.  I also have developed a lot of food allergies that I never had before, to foods I used to eat regularly.  I understand that you can develop food allergies normally, but I have developed a lot of food allergies, suddenly (all at the same time).
Received 6 vaccines (including varicella) and PPD test on 2/28. That night developed burning blisters apprx 6 in to the Lt. of her midline abd. area. Possible shingles, blister/vesicles still present, no s/s of infection. Referred to medical clinic.
The pt experienced a high fever of 102 on 4/21 - 4/25. Broke out in pox on 4/23/00, lasted 3 days. Also had runny nose, matted eyes, cough, no appetite. Gave Tylenol every 4-6 hours, bathed in oatmeal. Use calamine on the pox.
pt reported palpitations and shortness of breath 20 minutes after vaccination. pulse measured at 120/min, twice, 5 minutes apart.
Tonic clonic sz 27 hrs p/vax lasting 1 min, no fever, post ictal state 30 mins, followed by nl physical findings;
This spontaneous report was received from a licensed practical nurse and refers to a 5 year, 6 month old female patient. The patient had no known drug allergies. Upon general examination, the patient was found to be alert and active and in no distress. All examinations were normal. The patient has never had chicken pox. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose (improper product storage) of VARIVAX (Merck) 0.5 ml, lot number L008273, on the right vastus lateralis. Patient was concomitant vaccinated with M-M-R II. The patient's other medications included multivitamins. Outocme of the incorrect product storage was not known. There were no other adverse effects. This is one of the several reports from the same source. Additional information has been requested.