chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had chills, fever, felt not well on Thursday night. 10/24/02; went to concert and home to bed. Friday felt uckey, 10/25/02. Saturday 10/26, upper right arm, red; called clinic and sent to see MD. Placed on IV Cephalexin and 10/27 placed on Cephalexin 500 PO QID.
pt recvd vax & 1 wk p/2nd dose lost voice, devel throat tightness w/SOB & had periorbital swelling & redenss; no fever, rash or fatigue;
Swollen lymph node in armpit area that is very sensitive and it hurt for a few days; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash). On 10-Mar-2021, LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX (batch number MY2B2, expiry date 20th February 2021) for prophylaxis. On 30th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, several hours after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced SHINGRIX vaccine in right arm. The health care professional (HCP) reported that after few hours later after vaccination with SHINGRIX, the patient experienced shivering which lasted all through the night and into on the day of reporting and the patient still experiencing it. The reporter did not want to disclose patient information.
Body aches started 4 hours after injections, 12/15/10. On 12/16/10 facial swelling without itching or hives. C/O dizziness. Mother gave BENADRYL prior to calling office on 12/16/10.
Patient became nauseated and felt a swelling sensation in her throat approximately 15 minutes after receiving her second dose of vaccine. She was treated with 25mg of benedryl and 10mg of cetirizine.
sick every time I'm talking in bed 3 days sick; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves patient (unknown demographics) which made the patient sick every time the patient was talking in bed 3 days sick (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had sick every time the patient was talking in bed as was 3 days sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.
Fever (104); achy; sore throat; congestion; ear pain; difficulty hearing (said it was muffled); tired; This is a spontaneous report from a contactable other HCP. This 13-year-old other- HCP (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 12:30 PM (at the age of 13-years-old) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin, prior EM reaction when on Penicillin and received: 2 vaccines at 1 year of age and autism (high functioning) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took intuniv 2 mg for autism spectrum disorder. The patient experienced Fever (104), achy, sore throat, congestion, ear pain, difficulty hearing (said it was muffled), tired.  Fever improved with Tylenol Started with sore throat 15 hours after injection.  Symptoms began to improve 40 hours after injection on unspecified date on May2021 03:00 AM.The patient took treatment for fever with treatment drug as tylenol and no other treatment were taken for other events. The patient underwent lab test body temperature with result Fever (104) (unspecified date in May2021). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did received other medication within 2 weeks of vaccination. The patient prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not tested for COVID-19. The outcome of all events was recovering.   Information on the lot/batch is available. Other information is expected
sciatica; This case was reported by a physician via call center representative and described the occurrence of sciatica aggravated in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sciatica.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced sciatica aggravated. On an unknown date, the outcome of the sciatica aggravated was unknown.   The reporter considered the sciatica aggravated to be unrelated to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. The patient reported sciatica flare three weeks after receiving Shingrix.  The patient had a past medical history of sciatica and was in construction work that were potential reasons for his sciatica flare. As a result of this sciatica flare occured after Shingrix immunization. MD did not believe Shingrix was the cause of sciatica flare.  This was not a patient of the reporter, just someone who routinely gone to this reporter for medical advice.  Therefore, no other information about the patient had been provided. Medical Doctor reported that they had a pharmacist who told the patient that his sciatica was a known side effect from the shot. The patient was now contemplating not getting his second shot. The patient did not consent to follow-up.
Event: Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
3 - 4 days subsequent to receiving first and second doses of Lymerix pts upper arms starting aching, and joints in her hands started tingling. Physician concluded that the pt was experiencing a possible Lyme vax reaction and referred her to a rheumatologist. Approximately 2 months post vax the rheumatologist stated that four days after second dose the pt developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thighs.  The pt felt very stiff in the morning and described difficulty bending her hands. Pt stated that her neck was slightly stiff and she has some aching in the lower back. She denied rash, dry eyes, dry mouth, fevers, or fatigue.  She stated her appetite was good. She denied eye symptoms. The rheumatologist stated that he believed that this pts myalgias and arthralgias were related to the Lyme vaccine. He did not believed that the pts symptoms were related to the ulcerative colitis. Despite a low-positive ANA he did not believe that the pt had lupus or Sjorgen's syndrome. Pt was treated with Vioxx 12.5 mg daily and the rheumatologist concluded that he expected her to improve rapidly without any other treatment. The pt continued to report joint pain in both hands although not as severe as it was immediately after vax. The most recent information reports the outcome of the event as unknown.
20 hours post vaccination (dose 1 of the Moderna COVID 19 vaccine), I woke up feeling soreness in my left arm which is the injection site. I started feeling dizzy, a buzzing in my ears and broke into a sweat. I tried to stand up and walk over to my bed, but lost my balance and collapsed for about 5 seconds. Once I regained consciousness I stopped sweating, rested for a bit and then was able to resume normal function (drinking water, coffee, something sugary).
Rash to face & neck 1-2 hrs after administration of TD and Hep B. On 1/30/03 swelling to face, eyes, upper lip - went to ER.
Suspected Vaccination Failure / had the Shingrix shot(s) is "still has outbreaks" so he guesses our product isn't very effective; had the Shingrix shot(s) is "still has outbreaks"; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter did not know if the patients had a prior history of shingles or not. The reporter knew that everyone's, who had the Shingrix shot(s) was still had outbreaks so reporter guessed that GSK  product was not very effective. The reporter did not specify the number of persons or their gender or if they had received both doses in the series. The reporter stated that he did not know if they had a prior history of shingles or not. The reporter provided limited information. The permission to follow up was denied. This case had been linked to the case US2020015873, reported by same reporter. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
Chronic hives; ORC Benadryl at own expense. Course of 4 months with adverse affects.
Two primary & 1st booster were Pfizer. This 2nd booster was Moderna. Approximately 20 hrs after administration had sudden severe ataxia. Unable to walk even a few feet due to severe loss of balance. Speech remained clear & all extremities of  normal strength. Resolved by next day.
was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time 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 Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day).  Information on the batch number was reuqested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Information has been received from a woman in a doctor's office concerning a 7 year old male who on 03/09/1996 was vaccinated with a dose of varicella virus vaccine live. On 02/04/2002 it was reported that the pt "now" has chicken pox. The pt sought unspecified medical attention. Additional info has been requested.
red; Itching; hurting; like a sunburn /getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) 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.    No relevant concomitant medications were reported.  Treatment details included ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021:  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) 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.    No relevant concomitant medications were reported.  Treatment details included ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021:
Fatigue, shortness of breathe, arrhythmia, palpitations, foggy brain, anxiety
Formulation error:  administered 5-11y/o formulation to 12y/o+ patient
Fever; Muscle pain; Chills; Dizziness; Weakness; Headache; Eyes are so heavy; Pain in arm; I feel like, I want to be sleepy all the time; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on 14Apr2021 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. On an unspecified date, the patient experienced fever, muscle pain, chills, dizziness, weakness, headache, eyes were so heavy, developed pain in arm and felt like sleepy all the time. Patient stated that it's hard for me to get up I wanted to report because I did not know what to do, how long this going to be there these symptoms because I was allergic to ibuprofen, at the beginning I purchased it for allergy. Patient had been taking benadryl for fever, muscle pain and headache and reported that it helped a little bit, muscles are calm. I had been felling very bad and I did not know what to drink or what to take because I didn't call my doctor. Patient was scared because she cannot be able to work in job and was afraid of being fired. The outcome for fever, muscle pain and headache was recovering whereas outcome for other remaining events were unknown.  No follow-up attempts are possible. No further information is expected.
Redness, swelling on left arm.  Prelone given, otc Benadryl, rechecked on 12/13/07 at 2nd appt.  Redness gone, swelling down.  Still hard spots on left arm.
All 4 doses triggered EBV rash and fatigue.  With this 4th dose, the symptoms are lingering.  Enhanced vertigo, left side of body nerve pain, occasional burning headaches on the left side of head/brain, increased stiffness and crackling noise and feeling on left side of head, only.
Severe headaches followed by high blood pressure, achy joints, dizziness, high cholesterol, loss of concentration, muscle aches, dermatitis (severe). Also blood pressure tends to spike and drop.
Patient said he was experiencing difficulty swallowing about every 3 swallow and some facial tingling.
No other AE; received a dose on 02-DEC-2021 and the product expired on 05-NOV-2021; This spontaneous report was received from a pharmacist and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 02-DEC-2021, the patient was vaccinated with the expired 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot # S035355, expiration date was provided and also validated as 05-NOV-2021 (exact dose, strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The product did not have any known temperature excursions. No other adverse event (AE) occurred.
This report described the occurrence of soreness in a male pt who received Lyme disease vaccine (LYMErix) for prophylaxos. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received three injections of LYMErix "with the last in June of 2000 according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered soreness, stiffness of his foot and knuckles, tingling, headaches, and vision problems. The onset of his symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported.
headache, low grade fever, muscle/joint soreness, fatigue for about a day and a half.l
The day after my vaccination I had achiness and then fever and chills, one month later I began to have joint pain that has steadily gotten worse although I have never had this happen before then I began to have bumps in areas of my body which had tattoo's that are four to six years old. I am also having severe swelling in my fingers joints and knuckles.
Was called to the bedside by RN at the request of the family to further discuss care. They would like to continue with comfort care. We discussed the next steps for comfort care measures to be in place. They understand that this is terminal and do not want her to suffer. I have placed comfort care orders and discussed with the RN. Will remain available for further needs of the family and the patient.
Client in Observation area post vaccine, client reported feeling dizzy and lightheaded fainted and landed face down on cement.  Client responsive within seconds.  EMT and MD on site, assessed client. Vitals taken BP 132/73, HR 80, O2Sat 99% Blood Sugar 87. Client reports did not eat or drink anything this am. Client assisted to chair, was provided gatorade and pretzels. EMT assisting with providing   care to scrape to forehead.
MUSCLE PAIN AT INJECTION SITE AS WELL AS THE SIDE OF ABDOMEN AND RIGHT BUTTOCK.