chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncope; This serious case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received Men B NVS (Bexsero) for prophylaxis.   In OCT-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced syncope (Verbatim: syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported.   It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the syncope 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 Information: GSK Receipt Date: 09-NOV-2023 The nurse did not provide patient information but said she's had 2 patients experienced syncope after receiving Bexsero injection in the last month. The follow-up would not be possible as no contact details were available.
I became ill in the overnight hours on the day of vaccination, extreme fatigue, unable to get up and shower. Headache, extreme back and lower leg pain, I would describe as  worse than sciatic pain,  fever. Chills  Sore throat, runny nose, mild cough. Unable to resume normal function for two days. Loss of appetite, I slept the entire day following the injection. Second day, more fatigue, headache and body pain.  Profuse sweating .Symptoms seems to get worse with each injection. Tylenol had no effect, I had to take ibuprofen for relief which was short lived. Today is the third day and I am still fatigued, mild headache.
Patient reports a debilitating headache which started roughly 2 weeks after vaccine administration. We advised the patient to let her primary care provider know as soon as possible.
On 6/28/07-received Proquad, Hep A and Prevnar. Less than 48 hr. later, 6/29-0400, started wheezing w/difficulty breathing and cough and fever. Urg. Care 7/1/07 Prelone 3 mls dly x 5d, Xopenex meds q 8 hr.
- upper (R) arm red/swollen at injection site and warm to touch. - tender to touch. - fever noted 11/17/2011
Patient was given Moderna Bivalent vaccine.  Patient's age at time of administration was 13, the authorized age for the vaccine is 18 and older.   At time of VAERS reporting, no adverse effects have been reported.
Varicella-like rash started evening of 2/28/03 on stomach, then back, then a few lesions on chest over a period of 4-5 days. Inject site clear. Itching. No fever or other Sx's. Lesions scabbed over - cleared.
redness, swelling pain rt deltoid @ site of DTP w/in 8 hrs of inject w/low grade temp; seen @ clinic 24MAY w/induration & erythema 7x7 1/2cm;
The patient had came in for immunizations. The patient was given a expired vaccine on accident by one of the nurses. Due to this accident we have implemented a triple check system to ensure the validity of the vaccine.
FLU LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flu like symptoms. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, fever, and chills. This report was non-serious.
Swollen red arm.  The cellulitis was treated with Ancef.  It was believed that the arm discomfort woke her up during the night and she fell and fractured her hip.
Neck sore; Headache; extremely tired; feverish; achy all over; pelvis/hip joints ached all day; pelvis/hip joints ached all day; Aching in lungs late in day and sharpness in throat when I took a deep breath; Aching in lungs late in day and sharpness in throat when I took a deep breath; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included High blood pressure from an unknown date. The patient previously received first dose of BNT162B2 on Jan2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) and second dose of BNT162B2 on 05Feb2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) for Covid-19 immunization. Concomitant medication included influenza vaccine (INFLUENZA) taken for an unspecified indication from Feb2021 and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced neck sore, headache, extremely tired, feverish, achy all over, pelvis/hip joints ached all day and aching in lungs late in day and sharpness in throat when I took a deep breath on 14Oct2021. Outcome of the events was recovered on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Body aches, swollen glands, fever, headaches, soreness, sore throat, swelling, itching.
2 days, post vax, vomited X 1 and was lethargic "all day" on 11/10/01, "laying around on couch" with nausea and decreased appetite. Gave fluids and was doing better by 11/10/01 afternoon. No fever. Was hoarse but no sore throat. Mom concerned that the illness was due to shot, not viral GE.
No additional AE reported; HCP reported PNEUMOVAX 23 was administered after a temperature excursion to a patient.; This spontaneous report has been received from a medical assistant (healthcare professional (HCP)) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 20-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U003306, expiration date: 15-OCT-2022, administered once for prophylaxis (strength, dose, route of administration and anatomical location were not provided) after temperature excursion of 62 Fahrenheit (F) for 5 hours 12 minutes on 12-APR-2022 (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010789: US-009507513-2209USA000715: US-009507513-2208USA010861:
I have been experiencing symptoms of myocarditis or pericarditis?a feeling that my heart is fluttering, flushed, or murmuring and a general chest feeling of calm fatigue. I have never experienced these before. My partner and I have both been experiencing symptoms of some immune response to an infection or virus. Both of us have been experiencing: runny nose, some sinus pressure, mild sneezing, and sore throat. But I believe neither of us has experience fever or coughing. She is experiencing none of the chest/heart symptoms, only I am. Is it possible that I am related to other cases tying COVID-19 mRna vaccines in young men to heart inflammation?   I am otherwise a very healthy individual. BMI is around 22.4. Diet vegetarian. Moderate/low sugar and salt intake.
Fever for 2 days. Red rash on front neck for over 4 days.
Pt received Varivax on 7/1/99 - noticed rash on trunk morning of 4/11/08. Approx. 15-20 lesions, some beginning to crust over, slightly itchy.
Joint pain, especially knees; mid-back pain; chills.  NDC#:  58160-0823-11
26APR94 c/o neck hurting-h/a okay next day-28APR94 vomiting, t104 even w/APAP & Ibuprofen, sponging w/cool H20 & phenergan suppository for vomiting; adm to hosp 2MAY94 for dehydration; 3MAY94 devel fluid in abdo-did appendectomy;
My left arm developed a circular red rash near the injection site that was warm to the touch and itchy about 6 days after the vaccine. It is fading away 6 days later (3/17)
a spot that could either be a "pimple" or possibly an injection spot; This is a spontaneous report from a non-contactable consumer (patient) reporting himself.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via intramuscular route of administration, administered in arm on 28Jan2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a spot that could either be a pimple or possibly an injection spot. The patient received the first dose of the Pfizer COVID-19 vaccine 28Jan2021 (yesterday) and reports that he has no arm pain at all, the vaccination provider pinched the skin while administering the vaccine and when patient got home, he removed the Band-Aid and saw no blood and could not find a hole that would indicate where the injection went into his deltoid muscle. Patient stated that when he was looking for a hole in his arm where the injection could have gone in, he found a spot that could either be a pimple or possibly an injection spot, but it was not on the deltoid muscle. Patient questioned if the vaccine will still work if it was administered subcutaneously instead of intramuscularly and queried, if there was any difference in strength between the first and the second doses of the vaccine and what he should do regarding revaccinating in the event that he did receive an subcutaneous administration of the Pfizer COVID-19 vaccine yesterday. The outcome of the event was unknown.  No follow-up attempts were possible; Information about lot/batch number cannot be obtained.
Fever ranging between 99.6-100.6 (lasting 1 weeks) cough, runny nose/congestion (lasting 1week +)
8 days after vaccine I developed  a large, swollen, red, itchy rash that continues to increase in size
the interchangeability of Bexsero and Trumenba.; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Bexsero. On an unknown date, the patient received TRUMENBA. On 09-JUN-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: the interchangeability of Bexsero and Trumenba.). The outcome of the interchange of vaccine products 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 Information: GSK Receipt date: 10-NOV-2023 A Registered nurse contacted inquiring about Bexsero and what information is available about the information available for the interchangeability of Bexsero and Trumenba which led to interchange of vaccine products. They provided partial information about event, patient and vaccine. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
improperly stored vaccines; No additional AE information; This spontaneous report was received from a Health business professional, concerning a currently 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies and concomitant medications were not provided.  On an unknown date, the patient was administered improper stored vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number U022727 [expiration date 16-JAN-2023]) (dose, strength, and route were not provided) for prophylaxis. The vaccine was exposed to the temperature excursions: 6 degrees Fahrenheit (F) up to 14 degrees F (-14 degree Celsius up to -10 degree Celsius) -11.6 for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) information.
Headache; Fingers on right hand feel tight, like they're getting swollen; I could not move my right arm because of the pain; I could not move my right arm because of the pain; had pain and swelling around my right elbow; had pain and swelling around my right elbow; This is a spontaneous report from a contactable consumer or non-health care professional (Patient).  A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Batch no: unknown) via unspecified route of administration, administered in right arm, on 18Feb2021 (at the age of 65-year-old) as dose 2 single for COVID-19 immunization. Medical history included osteoarthritis, fibromyalgia. Known allergies reported as patient had some food sensitivities and meds. The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Batch no: unknown) via unspecified route of administration, administered in Left arm, on 27Jan2021 10:00AM as dose 1 single for COVID-19 immunization. No other vaccines received with in four weeks and no other medications received within in two weeks of vaccination. Patient had no covid prior vaccination and not tested for covid post vaccination. On 18Feb2021 17:00, Thursday afternoon through Saturday patient had pain and swelling around her right elbow. She could not move her right arm because of the pain. Fingers on right hand feel tight, like they were getting swollen. on 20Feb2021, Saturday afternoon headache came on really strong. AE was not resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for resulted AE. Clinical outcome of all events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
covid arm, same night, lasted several weeks patch about the size of a fist on forearm, left arm, developed patch of same characteristics on crown of head
Could not lift arm properly. Swelling, pain. Blanchable moderate erythema -> cellulitis. Treated with clindamycin.
experiencing sharp pain in left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 03Mar2021, outcome "not recovered", described as "experiencing sharp pain in left side".  Additional information: Patient was experiencing sharp pain in left side started last night and has come every couple of hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning an adult female with a history of varicella exposure who in approximately 2001 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that antibody testing showed that she failed to seroconvert. It was reported that the patient did not have documentation of the vaccination, but had verbalized that she was vaccinated. Unspecified medical attention was sought. Additional information has been requested.
Received the vaccine on a Thursday morning. That evening about 2 hours later I started to vomit. Late evening my left arm started to itch. Early morning Friday vomited twice with arm itching still. Arm continued to itch. Notice Monday evening that a welp 4x2 inch is noticeable with Redness in color.
I received the guardasil shot and started having rapid heart beats along with sharp pains to the heart. I have trouble sleeping at night because my heart beat so fast and have trouble breathing. I was prescribed Naproxen but it does not help. When I go to sleep, I'm awaken by fast pumping and pain in my chest. I have a hard time catching my breath and this started hours after receiving the shot.
Awoke with redness, swelling in am, by later in day redness and swelling had grown to 2 inches in diameter, warm to touch. Seen in urgent care, given cephalexin for cellulitis.
This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a 53-year-old female patient who received BOOSTRIX (batch number KJ4MS, expiry date 19th November 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 32BH5, expiry date 30th June 2016). Concurrent medical conditions included attention deficit disorder and sulfonamide allergy (causes angioedema). Concomitant products included alprazolam, Dextroamphetamine, amiloride and hydrochlorothiazide and zolpidem. On 22nd December 2015, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. In December 2015, less than a month after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site discomfort (serious criteria disability), weakness (serious criteria disability), injected limb mobility decreased (serious criteria disability), grip strength decreased (serious criteria disability) and joint clicking (serious criteria disability). On an unknown date, the outcome of the injection site discomfort, weakness, injected limb mobility decreased and grip strength decreased were not recovered/not resolved and the outcome of the joint clicking was unknown. The reporter considered the injection site discomfort, weakness, injected limb mobility decreased, grip strength decreased and joint clicking to be possibly related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant. On 31st December 2015, the patient visited physician assistant's office and reported that she experienced injection site discomfort at both the sites. The patient also experienced difficulty with movement, specifically described as difficulty in hooking bra along with trouble in raising her arms, range of motion issues, shoulder popping, shoulder weakness and lack of grip strength. The specific date of onset for all the events were unknown, it could be between 22nd December 2015 and 31st December 2015. The events were worsening at the time of reporting and the healthcare professional felt as though they were disabling. The reported batch number (328HS) for FLUARIX QUADRIVALENT did not exist and was updated to 32BH5 as per sales database.
Extreme leg pain/ leg muscle stiffness and leg muscle heaviness.  I?m a runner and former athlete, and I?ve never experienced anything like this.  My legs hurt and felt more fatigued than after I did an Ironman!  It started 6 days after the 2nd dose and is still there at day 9
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who experienced localized swelling and localized swelling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unknown date, The patient developed a non-serious localized swelling (localised oedema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious localized swelling (vaccination site swelling) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was localized swelling and localized swelling. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for localized swelling and as Unknown for localized swelling.
Since 2 February he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. He also notes flares with increased body heat. Lesions last less than 24 hours, spares his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 3 February where he was treated with oral antihistamines. He reports that early in his course he noted palpitations and ?chest congestion? but denies laryngeal, GI, and neurologic, symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 21 January, 12 days prior to onset of symptoms. He has used oral antihistamines with benefit. He initially felt his palpitations and chest congestion were due to use of cetirizine but subsequently tolerated this medication. He denies constitutional symptoms. UCT score today is 6 (1, 0, 1, 3, 0, 0, 0, 1). No history of adverse reactions to prior vaccines.
10 DAYS AFTER IMMUNIZATION BROKE OUT IN RASH OVER ALL SKIN ON BODY
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with M-M-R II (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No concomitant medications were not reported. No adverse effect. The outcome of administered doses that were outside the original box and exposed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
I did not have a reaction to the vaccine. On 07/30/2022 I noticed my head felt weird, I felt disconnected, and my nasal passages felt dry. I tested for COVID-19, and it was negative. On 07/31/2022 my symptoms got worse, and I tested for COVID-19 again and it was positive. I contacted my doctor on 08/01/2022 and was given the prescription for PAXLOVID. It took a day or two after starting PAXLOVID that I started feeling better. About two weeks later, I felt much better.
Red Itchy whelpy reaction spots all over about 50% of body. Started yesterday morning. Took 2 doses of benedryl so far.
Pt recvd vax & exp ocular edema, blurred vision & conjunctivitis; treatment steroids;
- double ear infection - oral thrush - mono - gallstones - sliding hitial hernia - internal hemoroids - UTI
had diarrhea immediately after administration; This non-serious case was reported by a physician via sales rep and described the occurrence of diarrhea in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, immediately after receiving Arexvy, the patient experienced diarrhea (Verbatim: had diarrhea immediately after administration). The outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Arexvy.     It was unknown if the company considered the diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter sent an email informing that a male patient received Arexvy vaccine 2 weeks ago and had diarrhea immediately after administration. No other information provided. The reporter did not consent to follow up.