chrisvoncsefalvay/vaers-outcomes huggingface dataset:
highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event; punctured IPOL was administered to patients post excursion with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA145332.  This case involves a 14 years old female patient who was administered punctured IPV (VERO) [IPOL] post excursion with highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes 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 HPV vaccine for Prophylactic vaccination.  On 01-May-2023, the patient received 0.5ml dose (dose 4) of suspect IPV (VERO) Suspension for injection of lot V1B902M and expiry: 02-Jun-2024 via intramuscular route in the deltoid NOS for immunization.  On 21-Mar-2023, it was reported that the suspect IPV (VERO) underwent temperature excursion where highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event (product storage error) (latency: unknown).  On 01-May-2023, the patient developed a non-serious event punctured IPV (VERO) was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency: 1 day).  No lab data was reported.  Action taken was not applicable.  Outcome: Unknown  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.
Intense tingling in her hands and feet; This is a spontaneous report received from a contactable consumer (patient). This 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose of bnt162b2 on 23Feb2021, and shingles vaccine on an unspecified date. The patient reported that 7 weeks after the administration of the second dose she started experiencing an intense tingling in her hands and feet that lasted for a week. She had a similar symptom after she received the first dose of the Shingles vaccine and her Physician recommended her to interrupt the immunization for Shingles. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented for Covid vaccination.  She had multiple allergies with history of anaphylaxis including to other vaccines. Patient insisted her PCP wanted her to get J & J vaccine. Patient received vaccine at 12:20 AND AT 12:30 C/O of losing voice and feeling like she was reacting.  EPI 0.5 given subq at 12:30.  BP 138/80; HR 60 and regular. At 12:38 symptoms were getting worse with raspy voice and feeling SOB.  Second dose of Epi 0.5 given subq.  BP 130/84; HR 64.  EMS called.  Arrived at 1300 and patient was transported to hospital.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 001B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 12:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 2:53 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 2:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported.  No treatment information was provided by the reporter.  Expiry date of the vaccine was 05 Jul 2022.  The vial was initially stored in the refrigerator on 19 Jan 2022.  The vials did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up appended, contains No new information.
Approx. 4 hours, post vax, mom noticed increased fussiness, complaining of leg pain and stiffness, non-weight bearing. Mom took child to ER with a questionable dx at the hospital. Today, he is moving better but slower than normal.
This case was reported by a consumer (patient's grandmother) and described the occurrence of low grade fever in a 2-month-old male subject who was vaccinated with DTAP vaccine (manufacturer unspecified), Rotavirus vaccine, Haemophilus influenzae type b vaccine and poliomyelitis vaccine inactivated (non-gsk). A physician or other health care professional has not verified this report. The subject's medical history included constipation, drug reaction and thrush. Concurrent medical conditions included sensitive to chemicals. On 16 December 2008 the subject received unspecified dose of DTAP vaccine  (details unknown), 1st dose of Rotavirus vaccine (details unknown), 1st dose of Haemophilus influenzae type b vaccine (details unknown), 1st dose of Poliomyelitis vaccine inactivated (Non-GSK) (details unknown). In December 2008, less than one week after vaccination with DTAP vaccine, Haemophilus influenzae type b vaccine, Poliomyelitis vaccine inactivated (Non-GSK) and Rotavirus vaccine, the subject experienced low grade fever, soreness and loss of appetite. The subject experienced the events after the vaccinations and the symptoms lasted for 2 to 3 days. In December 2008, the events were resolved. On 23 March 2010, the subject was vaccinated with Hepatitis A vaccine and experienced some of the same events plus different events. See case A0970857B for details. On 09 March 2012, the subject was vaccinated with HAVRIX and experienced some of the same events plus different events. See case A0970857C for details. Follow-up information was received on 27 April 2012 via consumer (subject's grandmother) who provided the subject's immunization record. On 16 December 2008, the subject received 1st dose DTPA-IPV-HIB, 1st dose ROTATEQ (other manufacturer), 2nd dose of Hepatitis B vaccine and 1st dose PREVNAR. The subject has had a long history of reactions to vaccines.
This spontaneous report as received from a certificate medical assistance refers to a female patient of unknown age. In 2008 the patient received the first dose of GARDASIL (lot #, expiration unspecified). On 09-AUG-2013 (today) she was in the office to get the second dose. No adverse effect reported. Additional information has been requested.
Cellulitis at injection site (4.1 x 3.3 x about 0.3 cm). Red and hot without lymphatic streaking or enlarged regional nodes. No fever. Tx: clindamycin.
3 minutes p/inject pt had syncope & fell to floor; placed on exam table & immed return of consciousness; pt had P60, BP 130/82; pale; devel erythema;
As per Fitbit monitoring, resting heart rate raised from 69 to 73 beginning the day after the injection. Resting heart rate stayed at 73 for 2 days then dropped to 72, 71, 70, 68 each day following. Has remained at the 68/69 level since.
Patient felt dizzy, nauseous, hot flashes after immunization.  I gave her an ice pack and she requested me to call the ambulance and they arrived to check her vitals which were normal and they advised her to hydrate by drinking some water.  We gave her a cold bottle of water and she felt better shortly after.
liquid component only given; liquid component only given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 25-APR-2023, the patient received Menveo. On 25-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid component only given) and inappropriate dose of vaccine administered (Verbatim: liquid component only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The nurse reported patient was administered only the liquid component of Menveo (unreconstituted), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
1/18 vaccinated; 1/27 pt started noticing hands are broken out in rash, hands started itching later that night, looked in mouth-sore on tongue/tonsils/face/upper body
Received call from patient 2-17-11 at 10:30AM stating that she has "pain & stiffness at her wrist, thighs, hips, & lower back". "I walk like a marionette". Denies fever, nausea and/or rash. No shortness of breath. Pt states that symptoms started 4 days after receiving MMR vaccine. "Walking better today but still painful".
Left arm was red,swollen, and warm to touch. Patient complained of arm itching and pain.
Pt recvd vax 28OCT93 & felt different, flushed, tingle from head to toes, panic-like feeling immed p/vax was administered; MD reported pt exp flu like sx (sore throat, fever, cough w/in 30 mins of administration; pt fatigued & myalgia w/ach
3 days after 2nd dose of Pfizer COVID vaccine she developed large erythematous rash with itching just below the injection site, no tenderness or fevers/chills, measured at 18 cm x 10 cm on 4/2/21 exam
Pain and swelling at injection site. ADACEL Sanofi C3355AA Exp 10-8-10.
This spontaneous report as received from a registered nurse refers to a 65 year old female patient. The patient's concurrent conditions and medical history were not reported. On 06-OCT-2015 at 03:00 PM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, right arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving viable ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX) was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
nausea; pressure/terrible headache; felt horrible; feeling lightheaded; Felt like passing out; Very sore; Very tired/very exhuasted; Bad arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt horrible) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION COMPLICATION (felt horrible). At the time of the report, VACCINATION COMPLICATION (felt horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant product use was not provided by the reporter.  Patient took advil 500mg and Ativan for her symptoms.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2021: No specific follow-up information recorded.
Mom stated almost 2 weeks after patient received vaccination for Flu, MCV4(MENACTRA) and Men B (TRUMENBA) she developed some rash/hives that started in her hands, forearm and knees. She aslo had some swallowing problems and had lactose intolerant. She doesn't know if its from the dairy or from the vaccine.  She doesn't know if patient was coming with something at that time too. They had seen the doctor and was prescribed Benadryl, Steroid and Zantac and has been taking it since then. they were also referred to an immunologist.
Pins and needles feeling in left hand; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 17Mar2021, the patient received Sars-cov-2 vaccine via an unknown route of administration for an unknown indication. The patient's medical history and concomitant medications were not reported. The patient had allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 09:00 hours the patient experienced pins and needles feeling in left hand. The patient did not receive any treatment for the reported event. The clinical outcome for the pins and needles was not resolved.   No follow-up attempts are possible. No further information is expected.
Rash at injection site 7 days after vaccination. Eight days after first rash appeared got 2 new rashes on arm of vaccination at different locations on arm
Rash is still there. Rash started the night after shot was given. Rash was on her stomach.
neck pain radiating to my shoulder blade; she felt uncomfortable near my neck on the evening of getting vaccine; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 07Feb2021 at 09:30 as single dose (age at vaccination was 38 years) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroid (take daily Synthroid tablets in the morning). Concomitant medications included levothyroxine sodium (SYNTHYROID) taken for hypothyroidism, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination. The patient felt uncomfortable near her neck on the evening of getting vaccine on 07Feb2021 and experienced neck pain radiating to her shoulder blade on 08Feb2021 around 19:30. The clinical course of event was reported as: she took the vaccine on 07Feb2021 at 9:30 and on 08Feb2021 around 19:30, she started a neck pain radiating to her shoulder blade. Note that she received the shot on her left arm and the radiating pain was from her neck (right side of her neck near throat) to her right shoulder. She never had this type of pain until now. If she took a deep breath, she felt intense pain radiating from her neck to shoulder blade. She did not do anything unusual and spent her usual workday (work from home) as normal. She even took a short nap early evening too. Yesterday (as reported) she just stayed home and relaxed after getting vaccine. After getting the vaccine, she felt uncomfortable near her neck on the evening of getting vaccine (07Feb2021). She did not know if she could conclude that this was an adverse effect to the vaccine or not but as a precaution, she was reporting it. If the pain intensifies, she will visit an urgent care tomorrow (09Feb2021). The patient was not COVID tested post vaccination. No treatment received for the reported events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
After a night of mostly not sleeping and shivering (feeling cold and hot), I got out of bed at 7:00 am and fainted twice on my way to the bathroom. I knocked out a front tooth, pulled a muscle in my shoulder, and cut my face in several places.
Started with sore thumb joint.  Progressed to intermittent tingling in hand, then forearm, then upper arm.  Note:  soon after vaccination I had inflammation and swelling at the vaccination site.  Physical therapy a month later revealed a knot of scar tissue and massaging this produced an onset of the tingling.
Fever ,chills,headache,unable to sleep 2 wks due to tartness of both leg muscles,lose of balance & leg strength, extremely tired loss of energy.
Patient complained about having a numbness sensation to her tongue, and anxious, no other complains of symptoms. Vital signs were taken. Patient refused benadryl and stated to have felt better at 1415.
Papular, erythematous and pustules over trunk; no vesicles, few scattered on lower abdomen. No oral lesions. Afebrile. Beginning on 5/20/02.
Injection site pain and swelling for 48 hours Muscle aches- severe for 24 hours; mild next 24 hours  Both side effects treated with ibuprofen
Restless leg sensations in both legs; aching, and urge to move. Onset 4:30 pm on day 8 after booster with Moderna Covid-19 vaccine.
EXTREME BODY ACHE; CRAY LEG CRAMP; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced extreme body ache, cray leg cramp, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme body ache, cray leg cramp and headache was not reported. This report was non-serious.
After being fully vaccinated, patient tested positive for covid-19.  First dose of Moderna 2/10/21 and second dose of Moderna 3/10/21.
Employee reported that approx 15-20 min after recieving vaccination became very nauseated, and anxious feeling. Was reported to medical staff.
after 10 mins after  shot , throat started closing up, voice changed became raspy, difficult to talk, arm slightly sore. Lasted about 20 minutes. Nurse name her drink water a take a cough drop. When i got home for a couple of hours i was itchy  in my throat area. Spoke to my Dr, advised to just take Benadryl. and keep an eye on it. Advised me not to get the 2nd injection.
Took PAXLOVID had high fever cough congestion pneumonia, had rebound case with sinus infection and fatigue severe headache.
Patient experienced lightheadedness immediately after vaccination. She sat for a moment with her head on her knees , was communicating with immunizer , then passed out onto the floor. She was unconscious for approx. 1  minute , she was breathing regularly . She urinated on herself and was rigid for a few seconds.  She regained consciousness and sat on floor , talking to the immunizer , until the paramedics' arrived , they assessed her and since she was still lightheaded , they transported her. She reported after the incident that she has been lightheaded and has passed out  before.  however, She had NO  adverse reaction to receiving a vaccine on the VAERS form
immediately gave her a follow up dose, a full dose; administered inadequate dose to consumer and then immediately administered another adequate dose to her (Consumer).; nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Sep2021 11:52 (Lot number: FC3184) at the age of 44 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Diabetes" (ongoing), notes: Patient Medical comments: Verbatim: Diabetes; "hypertension" (ongoing), notes: Patient Medical comments: Verbatim: Hypertension; "Stroke", start date: Jul2020 (unspecified if ongoing); "Menopause", start date: Jul2020, stop date: Jul2020. The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Sep2021, outcome "not recovered", described as "immediately gave her a follow up dose, a full dose"; UNDERDOSE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "administered inadequate dose to consumer and then immediately administered another adequate dose to her (Consumer)."; NERVOUSNESS (non-serious) with onset 13Sep2021, outcome "not recovered", described as "nervous".  Additional Information: Patient confirms she just received her first dose of Pfizer Covid 19 vaccine prior to call today on 13Sep2021. The vaccine provider inadvertently squirt some of drawn up vaccine from syringe and administered inadequate dose to consumer and then immediately administered another adequate dose to her. Patient is nervous and explains that she had a stroke last year from receiving a medicine.she had a stroke last year from receiving a medicine (medication/manufacturer not provided/ had a stroke as a side effect from another medicine. Outcome of reaction/event at the time of last observation: RECOVERING/RESOLVING  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a Registered Nurse, refers to a 19 year old patient of unknown gender Information about the patient's medical history and concurrent conditions was not provided. On 21-SEP-2015, the patient was vaccinated with an expired dose of VAQTA lot # J009441, expiration date 23-AUG-2015, (administration route was not provided). No concomitant therapies were reported. No adverse experienced were reported. Additional information has been requested.
Within 1 hour child developed angry outbursts and increase in self abusive behavior which has grown progressively worse.  We consulted a neuro psychologist & before follow up he had a seizure 8/27.
6 hours later, severe headache, neck stiffness, facial swelling, lasted 24 hours. This recurred with second dose, lasted several days.