chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a nose bleed from it and it was a regular nose bleed i did not go to hospital i. do not have nose bleeds and it only happened the day i had the shot haven't had any since and did not have any the day before wanted to make sure i reported this.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 20-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Pt was admitted with chest pain and thoracic arotic dissection 6 days after her second covid 19 vaccination. CT imaging showing a dissecting mid descending upper abdominal aneurysm. She was transferred to the ICU on an esmolol drip and ultimately transferred to hospital MICU where she remains hospitalized
rash present consistent w/zoster like along lt ant/lat & pos chest wall (painful) starting 5 days p/vax lt thigh;
Patient received an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received HBV (Engerix B) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: HCP reported that the patient received an expired dose of Engerix B on 21st June 2021, which was already expired on 3rd June 2021. The reporter consented to follow up.
Headaches in the front of head. back of eyes hurt when looking from corner of eyes. Everyday for the last few days. Never happened to me before.
Seizure with fever (Hx of previous seizures with fever). 3/13/08-records received for 12/20/07-Prsents after status epilepticus. Seen in ED for seizures, temp 103.3, lethargic, slightly confused. DX Seizure, Fever. Each episode started with coughing followed by vomiting except last seizure where vomiting followed seizure.
Chest Pain that developed hours after vaccination associated with fatigue, chills and lethargy. Consistent with Pericarditis
Flu like symptoms with fever and chills for two days plus large area of pain swelling and redness 3X5 inches at injection site for 4 days
For all intents and purposes the vaccine induced COVID 19 disease. Patient had recovered from previous SARSCoV2 infection in July 2021 (confirmed with positive PCR test at the time). Patient began to experience similar symptoms as experienced the during the previous infection within 30 min of receiving the vaccine. Symptoms included muscle aches and muscle weakness throughout the body, general fatigue, and headache, all as had been experienced in the previous infection. Symptoms were  sufficiently severe to warrant bed rest, as in the case of the previous infection. Symptoms persisted for 48 hours, c. 50% of duration / persistence during the previous infection. Of note, lose of sense of smell and taste was not experienced post-vaccine,  although had been experienced during the previous infection.
Fever Headache, earache Sore Throat General aches, pains Fatigue, weakness Stuffy nose, runny nose Sneezing Dry cough  Stomach symptoms: nausea, vomiting, and diarrhea
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored in June 2014 (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location, lot numbers were not reported). The reporter stated that the vaccine was evaluated by the Company and found to be viable and since then they were administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused to contact physician.
1/22/2021: Delayed reaction - mild, itchy rash spreading on/around injection site (about 2 to 3" diameter)  Day 1-3: Extreme soreness/sensitivity at injection site Day 6: Mild sensitivity at injection site, notice site around it turned pink Day 7: New rash spreading  on/around injection site
no additional AE; the administration of expired MMR II; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter (also reported as .5 ml, clarification had been sent) for prophylaxis (lot #T027935, expiration date: 18-AUG-2022, strength and route of administration were not provided) (expired product administered). The reporter also inquired viability of administered dose. No additional adverse events were reported (no adverse event).
1st dose 4 years ago, the shortage prevented 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The reporter reported that the shortage prevented 2nd dose. The patient asked should he/she get 1 or 2 doses now. Additional Supportive Information: The follow-up would not possible as no contact details were available.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received VARIVAX (Merck) (lot #K007783 and expiry date: 28-MAY-2016) which was improperly exposed to 22F for 144 hours. No known adverse effects reported. No product complaint was reported for VARIVAX (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440 and 1411USA004442 (same reporter link). Additional information has been requested.
Headache, muscle aches,chills, nausea, bruising at injection site.  Also tenderness in armpit,shoulder blades, and pectorals.  Loss of appetite and exhaustion.  Symptoms lasted through 1/30/2022.
A report was received from a healthcare professional regarding a 12 month old vaccinee. No details were provided regarding the vaccine's medical history or concomitant medication. On an unknown date the vaccinee received in Influenza vaccination, the vaccinee had also been vaccinated with the following on unknown dates, Varicella virus vaccine live, measles virus vaccine (Enders Edmonston), Mumps virus vaccine live (Jeryl Lynn), Rubella virus vaccine live (Wistar RA 24/3) and Pneumococcal vaccine. The vaccinee experienced a small amount of lesions on the body and fever elevated to 105 degrees F. The vaccinee was taken to hospital and was administered antibiotics. Laboratory studies were performed, but the results are unknown. The vaccinee recovered.
I had 3 shots and still had shingles\ suspected Vaccination failure; I had 3 shots and still had shingles; It felt like someone with a shovel digging under my skin; I had 3 shots and still had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin discomfort and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, skin discomfort and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and skin discomfort to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient had 3 shots of shingles vaccine and still had shingles. The patient received 3rd dose as extra dose which led to extra dose administration. The patient felt like someone with a shovel digging under skin. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory test confirming shingles were not provided.
Patient received the powder portion of Menveo mixed with Pfizer COVID diluent.  Both the Menveo and Pfizer pediatric COVID vials have same colored top.  Pt. observed for 15mins with no adverse event and/or outcome.  Pt will be advised to return to repeat COVID vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of patchy rash in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 16th August 2018, 2 days after receiving SHINGRIX, the patient experienced patchy rash. On an unknown date, the outcome of the patchy rash was recovered/resolved. It was unknown if the reporter considered the patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced patchy rash primarily on the left arm. The rash appeared about 2 to 3 days after the injection and resolved after 2 weeks. The lot number and expiry date of 1st dose was not known at the time of reporting. The reporter gave consent to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2019GSK037247.
Brachial Neuritis. Pain in vaccinated arm, joint pain in vaccinated arm.
My current peanut allergy got way worse than it initially was. When I walked pass my neighbors who were cooking with peanuts, I only smelled it. And when i got back to my apt I started itching on my back and I got hives on my front chest area.   I was only able to calm it down when in my apartment that was bleached and ventilated and that was after 30 minutes.  It was way worse than I just ate peanuts and had an antiphallic reaction. Technically this response to breathing  in peanuts and not being able to even in a room with the smell of peanuts started at the Moderna Covid 2nd dose. This never happened before- and this is the only adverse reaction I've been having.  And I almost died from having COVID in 2020 Nov.  I've had the anaphallitic reaction to peanuts since I was three years old (which is very severe to the point that I'm not able to have a allergy test because I could have a anaphallic reaction to the actual test), never had an airborne reaction to peanuts until after Moderna dose 2.
Pt recv vax on 8/20/98; on 8/22/98 pt exp swelling of face &both ears w/ rash.  Pt seen by M.D.; tx=Cyproheptadine liquid.
IgA nephropathy; This is a literature report for the following literature source: Kidney Med, 2021; pgs:10.1016/j.xkme.2021.05.0023427, DOI:10.1016/j.xkme.2021.05.00234278290. The Full Publication has been requested.  A 30-year-old male patient received BNT162b2 (BNT162B2), as DOSE 2, SINGLE (lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization. The following information was reported: IgA NEPHROPATHY (medically significant), 1 day after the suspect product administration, outcome "recovering." The patient underwent the following laboratory tests and procedures: ANCA (Antineutrophil cytoplasmic antibody): Negative; Antinuclear antibody: Negative; Serum albumin (Blood albumin): unknown results; Serum creatinine (Blood creatinine): 1.02; 1.03, notes: follow up; Blood urine: Positive, notes: Hematuria; Protein urine: 4+, notes: proteinuria. Therapeutic measures were taken as a result of IgA nephropathy.  Additional information: Treatment: RAASi (renin-angiotensin-aldosterone system inhibitor); Follow-up: 6 weeks; Recovery: Partial.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
no adverse event; expired vaccine was dosed to 4 individuals; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that expired vaccine was dosed to 4 individuals on 10-Jul-2023, 14-Jul-2023 and 17-Jul-2023. The  vial size was unknown. The vial was initially stored in the refrigerator on 10-Jul-2023. The vial didnot undergo any temperature excursions. No treatment medication was reported..   This case contains information about patient 1 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733876, US-MODERNATX, INC.-MOD-2023-733877, US-MODERNATX, INC.-MOD-2023-733879 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733877:Patient 3 US-MODERNATX, INC.-MOD-2023-733876:Patient 2 US-MODERNATX, INC.-MOD-2023-733879:Patient 4
8/16/2022 got covid. Horrible headache. Extreem tiredness   Loss of taste. No appitite. Mild fever    8/17/2022 severe stomac pains    Went to er but left ama.  Took about 2 months for exhaustion and fatigue to b manageable.   Experiencing joint pain all over.  9/12/2022 4th phizer BV vax  # GJ 2524 taken at facility along with the flu vax in left arm.  Fall 2022 -spring 2023 multiple sinus infections needing antibiotics  2/2023 severe stomach bug with vomiting and explosive diarrhea for almost a week. Needed antibiotics.  Was seen 2/17/23 at urgent care  3/23 sinus infection back and worse than ever.   Smell like a dead mouse in my face.  Recieved antibiotics on 2 different occasions from facility.  And a referal to ent.   Still have infection.  On wait list for ent  Currently still have joint and muscle pains everywhere.  Have not seen medical about it tho.  Trying to get appointment because becoming dibilitating
INCORRECT STORAGE OF VACCINE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 04-AUG-2022) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. Age at time of vaccination 70 years old. No concomitant medications were reported.  On 21-JAN-2022, the patient experienced administration of vaccine which was stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine which was stored outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558340, 20220558343 and 20220558451.
Fever; Chills; fatigue; Nausea; muscle aches; This non-serious case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 2nd dose of Shingrix. On 03-MAY-2023, 18 hrs after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), fatigue (Verbatim: fatigue), nausea (Verbatim: Nausea) and muscle pain (Verbatim: muscle aches). The outcome of the fever, chills, fatigue, nausea and muscle pain were not reported.   It was unknown if the reporter considered the fever, chills, fatigue, nausea and muscle pain to be related to Shingrix.     It was unknown if the company considered the fever, chills, fatigue, nausea and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAY-2023 The patient self-reported this case. The patient experienced fever, chills, fatigue, nausea and muscle aches 18 hours after receiving 2nd dose of Shingrix. The reporter was consented to follow up.
patirnt suppose to administer Pentacel vaccine, only administered the DTAP/IPV portion and did not reconstitute it with ActHIB, no adverse event; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was vaccinated with 0.5 ml  first dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in right thigh (batch number and expiration date not reported) on 15-Oct-2019. The patient received only DTAP/IPV portion of pentacel and did not reconstitute it with HIB (PRP/T) VACCINE [ACT-HIB].  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  Patient's medical history was not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  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.  Information on the batch number was requested.
Patient called 5-11-17 around 3:00 to report her dtr had a swollen red upper (R) arm. Immunization for DTaP/IPV and MMR-V given 5-09-17 afternoon. Mother reports a little red and swollen next day. School nurse also called, reported 4"x4" circular red area (R) deltoid. Dr. called and (I) her to take BENADRYL. TC mother 5-12-17 and mother reports still red and swollen, gave BENADRYL and she is back at school.
After having the flu shot, patient experienced pain near the joint in left shoulder. It radiated down left arm. Pain occurs intermittently and lasted about a month.
Severe headache, muscle and neck aches, fatigue, injection site pain. Injection site pain started that evening. The headache, aches and fatigue started Saturday and I was unable to get up out of bed. My head hurt whenever I lifted my head or tried to perform any mild activity around the house. I did not take anything for the pain as I don't really use any medications if I don't absolutely need to. The headache went away by Sunday morning, but the neck pain and injection site pain are still occurring (but less) by Monday morning.
chest pain, SOB and pain down my right arm (got injection in my left arm), lightheaded/dizzy.     Went to ED the next day state it was not myocarditis or PE. But too early to tell.
5 days after receiving typhoid vaccine, started having urticaria, low-grade fever, nausea, abd. cramping (mild), mild dizziness.  Our office did not administer this vaccine, so we don't have this information.
pt recv vax; devel hives; later, lost to f/u because " a file could not be located";
Patient reported raised, red, hard bumps that appeared all over her body with 8-12 hours after receiving Fluad. I recommended oral diphenhydramine and topical hydrocortisone, which she's already been using. The hives are the only noted reaction she reports. She also reported increasing dose of Carvedilol yesterday, and eating a dinner of steak, mashed potatoes, and green beans yesterday. I advised her to report this reaction to her primary care physician and to obtain further advice from physician as to whether she should seek medical attention immediately. She indicated no difficulty breathing, no tachycardia, or any other adverse effects. I also advised patient to immediately contact pharmacy with any further questions or evidence of progression of reaction.