chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm hurt worse after the first dose. The patient consented to follow up. This case has been linked to US2019229313, reported by the same reporter.
seizures; Had bad reaction; I had the wicked reaction; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on an unspecified date, at dose 2, single for covid-19 immunization. Medical history included asthma; did not use the inhaler every day, migraine and the patient  was immunocompromised (ongoing). Concomitant medications included cefaclor; fluticasone; oxcarbazepine; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date. The patient had booster dose of bnt162b2 on an unspecified date. The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003326 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 04-Oct-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003325, US-BN-2022-003327 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.
pt recv vax 23JAN96 & 24JAN96 pt exp a tingling sensation & numb feeling in lt arm & hand;also exp weakness in hand;25JAN96 pt recovered;
Information has been received from a registered nurse concerning a 7 year old male who on 22-Jun-2001 was vaccinated with VARIVAX (Merck) (lot# 635948/1333K). 0.5ml, SC. On 23-Mar-2008 the patient developed a chicken pox outbreak after receiving VARIVAX (Merck). Subsequently, the patient recovered from a chicken pox outbreak after receiving VARIVAX. It was not reported if the patient sought medical attention. Additional information is not expected.
Swollen red spots; Swollen red spots; Minor hives; Skin tingling and itching in both arms and hands; Skin tingling and itching in both arms and hands; This spontaneous case was received on 23-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04198) and concerned a 35-year-old, female patient.   The patient historical conditions included reconstructive surgery at right wrist and anaphylactic reactions to jalapenos, chocolate, cucumber, pickles and bees. The patient's concurrent conditions included allergies to unspecified pain medications, oxytocin, prednisone and steroids. The patient's concomitant medications included unspecified prenatal vitamins, used for an unreported indication.  On 20-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid of left arm and indication: not reported). The batch number reported was 283849 and expiration date: 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed swollen red spots, minor hives, skin tingling and itching in both arms and hands. The patient was treated with unspecified pain killer and Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 23-Oct-2020, the patient was recovering from the events.  The reporter did not provide causality assessment.  The reporter assessed this case as non-serious.  Company comment: All events were assessed as related to Flucelvax QIV.; Sender's Comments: All events were assessed as related to Flucelvax QIV.
Disruption of menstrual cycle. Period was regular after first dose of the vaccine. After receiving the second shot, I still have not gotten my period. Currently 4 weeks late and on day 65 of my cycle, which is usually consistent every 28-30 days. All tests taken confirm that I am not pregnant.
patient was given DTaP IPV portion of Pentacel without the Hib/No Ae; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a 6 months old female patient who was given DTaP IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the Hib (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 21-Aug-2020, the patient received a 0.5 mL third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AA and expiry date 22-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  Case details: reporter stated that the DTaP IPV portion was given but not mixed into the dry powder. She would like to know if the dose was valid and what to do regarding missed Hib.   It was an actual medication error case due to inappropriate reconstitution technique.  At a time of reporting no adverse event 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.
Intense migraines, body aches, loss of appetite, complete exhaustion for 48 hours.  Loss of appetite 6 days
I developed tinnitus approximately 10-14 days after the second Covid vaccine.  Within 12 hours of the vaccine, I had fever, chills, body aches, and headache.  These symptoms subsided and about 24 hours after the vaccine, I developed fatigue and heartburn.  These symptoms subsided with 3 days of the vaccine.  The tinnitus started 10-14 days later.  It is noticeable when there is no competing noise and is worse at night.
This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and medications were not reported. The patient had a stroke on 04May2021 and just recently returned to work. HCP stated that he was updating the counts of the Pfizer Covid-19 vaccine and took out a 25 vial box and left it on the counter at room temperature of 69 degrees Fahrenheit for 15 minutes.  HCP was asking if there was stability information of the above Pfizer Covid-19 vaccine. The outcome of the event was unknown. The lot number for [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of stroke cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
3 x 4 cm area of erythema and induration about 1 cm below injection site in left arm.
Patient experienced tingling and numbness in the neck, throat and ears. We treated with benadryl, and watched her. She left with her mother after 45 minutes of observation.
The patient is a 45 year old male with PMH including CLL. He did have a Covid-19 infection in 12/2021 and treated with monoclonal antibodies at that time. He received his most recent chemotherapy treatment for the CLL on 1/3/22. He states he does feel "foggy". He has been taking motrin recently but skipped taking it last night and noticed a fever. He called his oncologist and PMD today who recommended he come to the ED. In the ED, he was given cefepime and vancomycin. ID was consulted and oncology was consulted. He was started on IVF. His initial VS were BP 134/79, HR 87, RR 18, T 100.1, and sat 98% R/A. Platelet count was 86. He is being admitted to the hospital for further treatment.
Patient noticed on 4/5/08 at 2:00AM, soreness, itching and a knot on left arm where Zostavax was administered. Patient applied alcohol to help with itching. Patient states taking Tylenol on 4/3/09 until today 4/6/09 for soreness. States knot has gone done in size. Reddened area with two inch circumfurance present today 4/6/09, knot about the size of a quarter noticed. Recommended patient to apply ice to help with swelling.
2/23/2007 PC from pt. - was seen in ER 2/18/07 c/o rash - a "shot" was given. On 2/23/07, pt reports rash continues, hands are swollen and itching - referred to PMD. 2/26/2007 - Phone call - pt seen 2/23/07 by PMD - gave pt steroids and lotion. Reports is improving today.
at 4am on 12/23 she felt like she "hit a wall" (was working at the time) Went home and slept. Woke up on 12/23 @1pm and had fever, chills, rash, knot in arm, lymph node in armpit was swollen. Her throat then began to feel itchy, dry, tight so she used her epi pen. That helped. She did go to the ER but they just observed her and did not treat. She then went back home
I received the vaccine on 04/21/2022. On 05/28/2022 o started feeling a stuffy/ runny noise. the next day I had also an sore throat. I took a home Covid test and tested positive for Covid. After testing positive I called my doctor and was prescribe Paxlovid.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. In an unspecified date in 2011, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not reported) for prophylaxis. In November 2016, the patient was vaccinated with the second dose of GARDASIL lot # K008931 with expiration date: 04-MAR-2017 (route was not reported) also for prophylaxis. Furthermore, there was no adverse effects reported. At the reporting time, the third dose of GARDASIL had not been administered. There was no product quality complaint (PQC) involved. Additional information has been requested.
Shortness of breath, conjunctivitis, pain eye, back ache, fever, headache. This non serious case was extracted from the VAERS database via QSCAN on 11 March 2009. (reference number 247416). A 53 year old female patient had received a first dose intramuscular injection of FLUZONE SV 2005-2006, lot number U1904AA on 01 November 2005 and four to five hours later, she complained of her eyes burning and hurting, shortness of breath and fever. The patient also experienced a headache and back ache. The symptoms reduced over 24 hours. The patient did not seek care at the reporter's clinic and was reported to have been recovered from the event. No further information was provided.
5/26/12 Abdominal pain, decreased activity level x 4 days, temp 100.2 - 100.5.
After 1st dose vaccine, patient stated his left arm was numb with tingling, but no pain.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigerated after expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigerated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigerated after expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was placed in refrigerator on 18-Oct-2021. Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
I was congested with a small cough. I took a cold pill the night before; I woke up at 5 in the morning and was even more congested. I was visiting family, and tested the day before and it was negative. The next morning, I woke up and took an at-home COVID-19 test, and it came back positive. So I got up and went to a mobile clinic up some blocks. I took an antigen and PCR COVID-19 test, and both tests came back positive. I called my doctor back home when I got to a hotel to isolate; the doctor prescribed me Paxlovid and began my treatment. Now I'm feeling better and took at-home test yesterday that came back negative.
Patient called and stated that they had an injection site reaction. The site was very itchy, hot, hard. There was also some redness.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
My vaccine was on Monday morning, had the normal reactions, being very cold and a bad headache for about 36 hours.  The day after the vaccine, my heart started racing like crazy.  My left side of my neck and behind my ear hurt very much.  I have a blood pressure cuff and it would not register.  I was extremely scared and the beating of my heart was also noticeable through my clothing.  The following  Wed. 4/7 morning at 5am, the cuff finally registered and my blood pressure was 158/86.  I came to work on Wednesday 2 hours later and had the school nurse take my pressure and it was 150/80.  About 4 hours later it was 138/76.  The neck/ear pain was gone that morning.
Arm is still sore after 14 days. It was really bad for two days, got a little better, but is persisting. Not as sore as day 1-3, but still feels like a dull and sometimes acute muscle ache, like I had an intense workout or have been injured.  Two weeks seems like a long time for it to still hurt.
Date of first H1N1 12/7/09 not noted by nurse - given #2 H1N1 12/11/09 (4 days later). CDC called, no injury #2 must be repeated 1-13 days after.
cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.
Two days after vaccination, patient reported noticing a rash around injection site that itches, about the size of a post-it note. Called to report on Sunday, four days after vaccination.
body aches; muscular pains; Chills; Bone pain; Fever; uterus pain as if I were about to get my period /uterus is hurting; nausea; vomiting; fatigue; gastritis; period lasting 2 weeks/early menstrual period; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16May2021 (at the age of 46 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation and experienced fevers, nausea, vomiting and early menstrual period that lasted for 15 days. On an unspecified date, consumer reported that she was so terrible, since 2 days ago she have had body aches, muscular pains and she was in bed right now. Consumer reported that yesterday she got her second vaccine dose and afterwards has experienced chills, bone pain, body aches, fever, nausea, vomiting, gastritis and once again, uterus pain as if she were about to get her period and her uterus was hurting along with fatigue, an early menstrual period, a period lasting for 2 weeks. She also took omeprazole for her gastritis. Consumer reported that she has never experienced this before, and reports having gone to the emergency room twice (not admitted to the hospital) where she reported being told that this was a normal side effect from the vaccine. Consumer reported that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The outcome of all events as unknown.  Information about lot/batch number has been requested.
suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088501:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:
Swelling and heat in arm, rash down arm of injection, dfficulty breathing/swallowing.
Pt experienced head (temples) and inner ear throbbing/pulsating without pain. Pt had symptoms starting Saturday and reported it Thursday as sx continued.