chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2 vaccines on 9/28 the Flu and pneumonia. The next day I could tell my temp was up. Normal for me = 97.8*. My temp was 99.4* Right arm was stiff and achy. There was a red welt the size of a quarter 3" below the injection site. It was hot, hard, and painful to the touch. By 9/30 it had grown to 3 x 4" in almost the shape of a big butterfly. I went back to pharmacy and the pharmacist told me to apply hydro cortisone to it. I added ice packs because the whole area was so hard, painful, and warm to the touch. He said if it didn't go away to go to a walk-in clinic.
wrong vaccine Adacel (Tdap) was administered to an infant, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00630973) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 6 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6900AA and expiry date was not reported) via unknown route at an unknown administration site (product administered to patient of inappropriate age) for prophylactic vaccination on 04-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  The reporter needed to know what she needs to do from here? She states that she administered the wrong vaccine (adacel) to an infant on Friday. what do we need to do? Is there anything to watch out for?"  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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.
On February 18, 2021 between hours 18:20-18:40 and a week after taking the second shot, patient lost balance (fainting) at home, fell, bruised a rib and fractured skull, causing subdural hematoma (bleeding outside of the brain). Bleeding stopped and several CT scans were performed. Under medical supervision, an anticoagulant medication was stopped to allow for healing. On February 20, 2021, moved from ICU to regular hospital room and on February 23 moved to another hospital for intense rehabilitation. Within days a thrombus developed causing a minor Cerebrovascular Accident, which was immediately identified by a medical doctor and nursing staff. On March 2, 2021 at 10:30 am  moved to a Medical Center for further treatment. An endovascular thrombectomy for the removal of a thrombus was performed by a doctor. After recovery in the Neurosciences Critical Care ICU, under amazing care by the doctors, further thrombi developed on patient's lungs and around the bowel. Patient expired at 8:01 on March 4, 2021 due to Ischemic Complications of Thrombi/Thromboemoli.
Swollen about the size of an egg at injection site, heat, redness, tenderness. Arm became swollen after about 18 hours and has remained pink, swollen to the size of an egg, and warm since.
Pruritis and peri-orbital edema bilaterally with hyperemia of the congestiona nd tightness in throat caused within 20 mins post injection. Treated with epinephine 1:1000 solution 1cc SQ and Benadryl 50mg IM then Allegra 180mg PO bid. Cold pack applied to both eyes; was within normal limits during episode. Throat and chest were clear, edema abated. Discharged home after observation ?
first dose over a year ago, late second dose; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago via intramuscular on unknown deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The case was reported by patient himself. Age at vaccination was not applicable for this report. Till the time of reporting patient did not received the 2nd dose of Shingrix which led to incomplete course of vaccination but was planning to get the second dose. Patient declined to provide any demographic information. Reporter did not consented to follow-up.
10/6 evening began to have flu-like lower GI symptoms. 10/7 woke up with severe lower backache and joint pain, cramping and nausea. This continued thru the day with low grade fever. 10/8 same symptoms but less severe. 10/9 no symptoms.
Contracted Auto Immune Disease Oral Lichen Planus Upon waking the day after the vaccination I had high fever, soreness, and extreme pain throughout entire body, especially in the mouth including sores in my mouth.  The  mouth pain has continued with sores and extreme physical pain through out the entirety of mouth.  Continued sore lymph nodes in the neck, as well as low grade fever. Symptoms have not abated in the mouth since the shot, and haven gotten progressively worse.
2 days after vaccine, Stiff neck left side, sevier pain from left  neck to shoulder down to arm. Unbearable pain that keeps me up at night.  Went to ER on Saturday.
7 days p/vax pt exp a varicella like rash w/greater than 50 lesions. addl info requested
Rash and tingling lips approximately 40 minutes after Pfizer-BioNTech COVID-19 vaccine 0.3 mL injected IM into the left deltoid. Presented to ED to report symptoms. Symptoms mild enough that patient did not want to have any interventions. She just wanted to report them for tracking purposes. Instructed to return in symptoms worsen or if new symptoms develop.  Patient did not return, so assuming no new or worsening symptoms.
fell off the bed and could not get back up; very weak/Moves around with help; weak knees; legs ache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weak knees,legs ache,Fell off the Bed and could not get back up and has been very weak.  The patient's medical history was not reported. Concomitant medication was not reported.  22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 22-FEB-2021, The patient experienced weak knees,legs ache,Fell off the Bed and could not get back up and  has been very weak.She lives with someone whom helps her move around.  No Laboratory details provided.  treatment information- tylenol was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fall,asthenia,arthropathy and leg pain is Unknown.
arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back and thigs; constriction of the windpipe; This is a spontaneous report from a contactable consumer who reported for herself. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 64 years, on 09Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included back pain, fibromyalgia, restless legs syndrome, depression from 1987 to an unknown date, headache, hyperthyroidism. Concomitant medications included gabapentin (GABAPENTIN) taken for restless legs syndrome, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for depression, start and stop date were not reported; methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for headache, start and stop date were not reported and apixaban (ELIQUIS) taken for an unspecified indication from Feb2021 to an unspecified stop date. The patient received first dose of COVID vaccine BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced hives on legs, top of the arm and swollen lips/lip swelled really big. The patient stated, "I have had both shots of the COVID Pfizer and that the first time I had it, I had some symptoms about  a little over a week out. What I had was hives. It is not that real big. This time, I have been about a week out. I was starting to have have hives and I keep having them. They are not just complete blocks just all over but spreaded and I am having kind of constriction of my wind pipe also (14Apr2021). Is that a symptom to that with the COVID virus, the shot. Yes, last I had was April 9th and I am still having spots coming out of me and I am taking Benadryl like crazy and today I  have still got them on me, you know the spots and I have like something is cutting my wind pipe off, you know, constriction, you know it's not all the time but its quite a few times a day on that and I am wondering if that. When I started having the problem. The first vaccine I had on night on March 19th and about a week and a half, I had about, I would say 8 to 9 days after that. I started having the hives and then I had a real bad frozen layup out of that (further not clarified) but the second time I had the vaccine also the night and I had the hives about a week out and then I have had constriction of the wind pipe that just completely chocked me out." The patient stated that after the second dose she had arm soreness, tiredness, hives that is getting worse on legs, stomach, breast, on head, arms back and thigs and constriction in the wind pipe. She took Benadryl and Phenergan for it. Therapeutic measures were taken as a result of constriction of the windpipe and urticaria. The outcome of the event constriction of the windpipe was not recovered while other events were unknown.
1st Moderna Vaccine March 9, 2021  LEFT ARM- - Day 5 LEFT ARM delevoped large red hot rash pain,itchy  raised area extending about 5 inches around site of injection lasted for 14 days afterwards.. Went to Dermatology after having rash, pain for over 10 days. Dr.  prescribed RX  steroid cream Triamcinolone Acetonide Cream 0.1% to rub on rash, advised to take Tynenol and Claritin.   2APRIL 3, 2021  RECEIVED  2nd nd BOOSTER MODERNA VACCINE IN RIGHT ARM . On  4th Day afterwards my RIGHT ARM developed same rash and all as described above. Called Dermatology for doctor to refill same cream Triamcinolone Acetonide Cream 0.1% as Ieeded for left arm.
Ringing in both my ears onset 3 hours after FLU shot, severe ear pain and pressure. Doctor prescribed diclofenac potassium 50mg.
Temperature 101.7, pain at injection site.  Advise Tylenol for temperature.  Cool compresses to site.  Call if symptoms change.
got a large hot rash on arm where vaccine was given, below the injection site; This case was reported by a nurse via sales rep and described the occurrence of heat rash in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced heat rash. In December 2021, the outcome of the heat rash was recovered/resolved.   It was unknown if the reporter considered the heat rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 patient received a dose of Bexsero in unknown arm and within 24 hours on 24th November 2021, the patient got a large hot rash on arm below injection site and lasted for about two weeks. The reporter consented to follow-up.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's son at conference, medical booth. The patient's age at vaccination was not reported. The patient received SHINGRIX and experienced local pain at the site of injection that progressed through out his body. All these events lasted for 3 months. This case has been linked to case US2019GSK058297, reported by the same reporter for the same patient.
patient felt very light headed, sick to her stomach, face was very pale, vomited up some water she had just drank
No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies was provided.  On an unreported date, a temperature excursion involving Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T035720 has been verified to be valid as syringe formulation, expiration date reported and validated as 15-APR-2022) occurred. The vaccine was improperly stored at a temperature of 48.9 degrees Fahrenheit for a time frame of 30 minutes. There wasn't a previous temperature excursion.   On 23-SEP-2021, Hepatitis A Vaccine, Inactivated (VAQTA) was administered to the patient after the temperature excursion occurred (administered dose, and vaccination scheme were unknown by the reporter; dose number, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Initial report was received from a health care professional on 15 October 2009 which involved a cluster of seven patients, male and female, who were 26 years of age and older. This case represents one adult female patient. An adult female patient (age not reported) with no known allergies and no concurrent illness had received a 0.5 mL intramuscular deltoid injection of FLUZONE, lot number U3216AA on 16 September 2009 and an unspecified amount of time later that same day, the patient developed a scratchy throat, hives to chest and her eyes felt funny. The patient took BENADRYL and the events resolved in one hour. The patient's past medical history was not reported and it was unknown if she had been taking any concomitant medications. No additional information was provided at the time of the report. The remaining six patients have been captured in case numbers 2009-04359 (four patients), 2009-04360 (one patient) and 2009-04361 (one patient). Documents held by sender: None.
8pm, 4/7/21--chills, temp 100.0, extreme body aches, tired; lasted about 5 hours before falling asleep (took tylenol but didn't work well) 8am, 4/8/21--everything resolved except aches, all muscles sore 2pm, 4/8/21--still achy but now nose starts feeling irritated, like I have a cold and throat becomes a bit irritated/scratchy 4pm, 4/8/21--extreme body aches return, chills too, could not take body temp at this time; took tylenol and by about 7pm, most symptoms were resolving
21SEP93PM loud cont crying, lt thigh swollen & red; pain caused discomfort & crying;
Warm around the injection site; itchiness around the injection site; pink around the injection site; swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm around the injection site), INJECTION SITE PRURITUS (itchiness around the injection site), INJECTION SITE ERYTHEMA (pink around the injection site) and INJECTION SITE SWELLING (swelling around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) 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 19-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm around the injection site), INJECTION SITE PRURITUS (itchiness around the injection site), INJECTION SITE ERYTHEMA (pink around the injection site) and INJECTION SITE SWELLING (swelling around the injection site). At the time of the report, INJECTION SITE WARMTH (Warm around the injection site), INJECTION SITE PRURITUS (itchiness around the injection site), INJECTION SITE ERYTHEMA (pink around the injection site) and INJECTION SITE SWELLING (swelling around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Recieved my 1st moderma vaccination 8/20/21 felt sick a few hours later with many strange  symptoms woke up the following day, with dry hacking cough, headache, body aches, sharp pain under left rib cage, fullness in right ear. Around aug 26th-27th dry hacking cough and right ear completely blocked and full feeling.  First week of september my hearing was completely gone in right ear and episodes of vertigo along with cough still.  had 2 chest x rays, cough was hard enough to keep me awake and feel like i broke a rib. both xrays negative. had ear looked at 3 times all said it looked ok one saw a little fluid.  later in september went to primary care who reported large amount of fluid and diagnosis of Acute otitis media with an effusion i was referred to ENT for treatment he also did a hearing test. first appointment with Dr ENT 9/27/21 more extensive hearing test showed moderate conductive hearing loss and confirmed diagnosis. 10/6/21 went back to ENT for Myringotomy. cough still present hering improved but ear could fill back up i was told will return in 3 weeks for follow.
Started experiencing ringing in the ears 4-5 days after the 3rd shot which hasn't gone away or subsided.
Got both Vx 1-2 yrs ago, now maybe shingles / Suspected vaccination failure; The beginning of shingles; her left buttock became sore to the touch; black and blue; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml and the 1st dose of Shingrix (unknown arm). On 03-MAY-2023, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Got both Vx 1-2 yrs ago, now maybe shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: The beginning of shingles), tenderness (Verbatim: her left buttock became sore to the touch) and skin discoloration (Verbatim: black and blue). The outcome of the vaccination failure was unknown and the outcome of the shingles and skin discoloration were not reported and the outcome of the tenderness was not resolved.  It was unknown if the reporter considered the vaccination failure, shingles, tenderness and skin discoloration to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles, tenderness and skin discoloration to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was the patient herself and reported that, she received both vaccines of her Shingrix vaccine one or two years ago, in an unknown arm. She reported that, two days ago her left buttock became sore to the touch. She stated that, it felt like it is black and blue, but it was not discolored. The reporter thought that, maybe the Shingrix vaccine was wearing off and this was the beginning of shingles. The reporter had denied consent to follow-up. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Client states woke up with diarrhea at 1:30 am and has continued since. Has vomited one time yesterday.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 05-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Patient reports that after administration of vaccine, she has felt a very strong pain in her left arm and cannot sleep or barely use that arm. She is taking naproxen and is relieving the pain but it comes back.