chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an advanced registered nurse practitioner concerning a female patient with no drug reactions/allergies, who on 10-DEC-2008 was vaccinated subcutaneously with 0.65 mL dose of ZOSTAVAX (Lot # 663196/1417X). There was no concomitant medication. Within 48 hours of vaccination, the patient experienced pain, tenderness and redness at injection site. Additionally, the patient felt pain in her spine at T6 to T7. The patient had been taking Ibuprofen (ADVIL) and was using a heating pad and was feeling better. The patient had missed two days of work because of the pain in her spine but she was returning to work on 16-DEC-2008. Pain in her spine at T6 to T7 was considered to be disabling. This is one of several cases from the same source. Additional information has been requested.
Patient reported to her Dermatologist  that two weeks following  her Covid vaccine (Pfizer) in 3/2021 she developed she had a significant eruption of tense blisters heavily effecting her BL lower extremities.
expired ActHIB (expired 7 days ago) was given to a 21 month old this morning/No AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 21 months old female patient who received a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ActHIB] (lot UJ055AAA, diluent lot U6205AC, expiry date 22-Apr-2020) on 29-Apr-2020, via intramuscular route in the left thigh for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse effects had been observed.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported experiencing rash and hives after recieving her first dose of the vaccine. After her second dose, she noticed her skin started to become bumpy and red around the injection site. Patient also reported bleeding under the skin. Patient was referred to primary care physician and dermatologist.
Upset stomach, headache, nausea, back pain, loss of appetite, fatigue, pain in injection side for more than 24 hours
Itchy, warm rash at and distal to site consistent with rash/allergic reaction more than cellulitis.
Janssen Covid-19  Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extreme fatigue, dizziness, and sleepiness.  About 1 hour later I started getting the cold chills, a headache and shaking.  About 1 more hour later I had a fever, achy joints and muscle aches.  The symptoms lasted through the night until about 8:30 the next morning when I started sweating.  I decided then to take aceteminiphen and Naproxen.  This helped me to feel a little better.  Side effects were resolved after 24 hours
Interchange of vaccine/it was noted the patient had actually started the MenB series with Trumenba; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 05-JUL-2023, the patient received Bexsero. On 07-JUN-2023, the patient received TRUMENBA. On 05-JUL-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Interchange of vaccine/it was noted the patient had actually started the MenB series with 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-JUL-2023 The patient had requested Bexsero be given and it was not until after dose was administered that it was noted the patient had actually started the MenB series with Trumenba, given. The lot number requested on call but not available at time of call.  The reporter consented to follow up. The reporter reported that a patient was given a dose of Bexsero.  The patient received Trumenba after Bexsero , which led to interchange of vaccine products.
3/11/09 got shot within a week behaviors change, he got weak, tired and on April 2009 he had a hard time doing school work and became violent - May 2009 regress a lot, Sept 2009 started drooling barely moving - Catatonic stage, Oct 2009 BM and soiled himself, treatment Oct. 2009 heavy metal detox, hyperbaric therapy, cognitive test.
About 90 minutes after receiving flu shot in L.D. child reported to grandfather that he could not move his (L) arm. Grandfather instructed to call PCP and left to take child to PCP.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted and fell off the chair in front of the immunization room for post-vaccination monitoring. There was about an one-inch long rug burn on his right forehead and a quarter-inch burn under his right eye. First aid was immediately applied. According to patient and his mother, previous history of post-injection faintings has occurred. Patient declined hospital and emergency care.
Only the Adjuvant Suspension Component was administered. It was not used to reconstitute w/ the Lyophilized gE Antigen. Our office was unaware of the error until after the patient came back to the office for her second dose in April. We have informed the patient and she is scheduled to come back to the office for another Shingrix vaccine in May.
sneezing often; very congested; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 28Mar2021 at 18:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication which the patient received within 2 weeks of vaccination included birth control and steroid taken for asthma from an unknown date. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19, which included nasal swab test on 11Mar2021 and resulted negative. On 29Mar2021 at 20:00 (24 hours after vaccine), the patient experienced very congested and sneezing often but the patient was not sure if this is related to the shot. Treatment was not received for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events congested and sneezing often were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symtoms; shot 2 was worse and last several days; lump in armpit; neck,shoulder,head ache so bad could not even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergies" (unspecified if ongoing), notes: Known allergies: sulfa; "Penicillian allergies" (unspecified if ongoing), notes: Known allergies: Penicillian. Concomitant medication(s) included: LOSARTAN. Past drug history included: Hycodan, reaction(s): "allergies", notes: Known allergies: hycodan; Codine, reaction(s): "allergies". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown; Site of vaccine administration: Left arm), administration date: 09Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "102 temp", "neck,shoulder,head ache so bad", "neck,shoulder,head ache", "neck,shoulder,head ache so bad", "could not even sleep", "flu symptoms". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu symtoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "shot 2 was worse and last several days"; AXILLARY MASS (non-serious), outcome "unknown", described as "lump in armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, every shot got worse. Patient was very active but, fear that her system was allergic to something in it. Work full time in an office and fear getting Covid as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myalgia, arthralgia starting at injection site and same side of the neck.  Now at times in both arms.  Worse in the morning.  No weakness.
Patient reported it happen on 6/2/17 the area on left deltoid became red and itchy.
Completely skipped my menstrual cycle that should have started the next day. Then I did not have another cycle until December. So from August to December I did not bleed. Then starting the first week of December I bled for 8 weeks straight with a lot of heavy blood loss and huge clots. I ended up having to have a D&C and a uterine Ablation to stop the bleeding. My hemoglobin was staying around an 8 or 7 until I had the procedure.  This is the first time in my entire adult menstral cycle that I have not been normal to the date of starting and I have never had problems or heavy bleeding at all before. Now out of the blue I am having to pay for surgery bills to cover a D&C and ablation.
After administration of vaccine patient began to complain of chest pain that was located on the left side radiating to the back.
Makes me sick; Initial information from  received on 29-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who had sick (Illness), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, made the patient sick (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
first dose on Jan 2020 and she would like to received second dose today; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in January 2020).   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 were provided as follows: This case was reported by the patient herself who was also a retired physician. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The patient was about to receive the second dose on 29th September 2021 but was looking for some guidance first. The reporter did not consent to follow-up.
Patient has an active outbreak of shingles on his left temple and around eye after receiving dose of Shingrix on 9/22/2020. He is being treated for the shingles. Unknown if this is related to the vaccine but we are reporting the event as it is on the same side as his vaccine was administered and so close to the date administration.
This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9(lot # M043731, expiry date: 26-JUN-2019) (incorrect product storage) reconstituted with sterile water diluent. The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007422: US-009507513-1708USA007425: US-009507513-1708USA007441:
Patient received single dose vial of PREVNAR 13 in left upper arm late morning on Dec 6th 2018. Patient reported to me, her daughter, that next morning, Dec 7th 2018, she was violently vomiting, was dizzy, and felt very weak. Patient also developed fever that day. Patient then stated that during night time hours into the following morning of Saturday Dec 8 2018, she was still feverish and had profuse sweating. Fever then dissipated on Saturday Dec 8 2018. Following day Sunday Dec 9th patient was homebound and felt very dizzy and weak. She did not want to go to the urgent care clinic as she thought this was a reaction to the injection and was told by the RN that she was sensitive to it and the reaction was normal. On Tuesday Dec 10th around 5 PM in the afternoon, the patient showed me her left upper arm where the injection took place as she said it was very sore. The arm was bright red from the shoulder down to the elbow, swollen and very hot to the touch. I immediately called Dr.'s office, but it was closed. The On Call triage nurse advised that she should be seen by Dr. the next day and to use warm moist compresses on the site to alleviate pain. Patient was then seen by Dr. on Wednesday Dec 11th and was given a 7 day dose of antibiotics for cellulitis.
Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017; L024993, expiration date 17-OCT-2017), which was improperly stored at 61.03 F for 3 hours 38 minutes.  The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA006817: US-009507513-1612USA006815: US-009507513-1612USA006816.
Information has been received from a 60 year old female with no relevant medical history reported, who on 25-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck), Lot number 659268/0158X, 0.65 mL, subcutaneously.  There was no concomitant medication.  The caller reported that at the "end of July" on approximately 30-JUL-2008 when her left big toe "bends up" while she was walking, she sometimes experienced "nerve pain" in that toe and the top of her left foot.  In August 2008, the patient discovered she had leukemia and reported that she "was immunocompromised at the time she was vaccinated".  The patient sought medical attention.  At the time of the report, the patient had not recovered from "nerve pain" in her toe and the top of her left foot.  The patient's outcome for leukemia was not reported.  Upon internal review, leukemia was considered to be an other important medical event.  Additional information has been requested.
PT STATING THAT HE WAS HAVING DIFFICULTY MOVING HIS RIGHT ARM AND THAT IT WAS VERY PAINFUL.
Reaction to TDAP vaccination.  Severe swelling (size of a plum) in lymph node in arm pit on the arm where shot was administered.
Itchy and swollen (hardtop the touch) arm at site of injection 7?9 days after.   Took antihistamine one time.
Red, itchy rash to the face. Took Claritin, Singulair, and topical hydrocortisone without change. Started on oral Prednisone today.
On 9/1/00 AM, child had a fever of 105-106F. Went to ER on 9/2/00 and treatment by clerk as provider on Medicaid said appointments available at office. Provider called and pt referred back to ER and was treated with Motrin which lowered fever to 103F. Took child home and treated with Motrin which would bring fever down. By 9/4/00, it was 101F and below. Varicella-type rash started on 9/4/00 at site of vaccine that quickly spread "all over-head to toe". Fever decreased. On 9/18/00, mom states rash is almost gone.
Narrative: Upon review of her history, she was diagnosed with PE at hospital on 6/28, 18 days after her second Moderna vaccine (given on 6/19/21 at non hospital site). She was initially treated with heparin then apixaban, but had worsening symptoms despite no missed apixaban doses and switched to lovenox then bridged to warfarin on 7/4/21 and discharged on 7/6. She presented to hospital and admitted for PE 7/7/21 treated with fondaparinux bridging to warfarin. Prothrombin Gene and Factor V Leiden genes were both negative, and B2glycoprotein and Anticardiolipin Ig G an IgM antibodies were negative but additional hypercoagulability testing was not done.
This spontaneous report was received from an unspecified source, concerning a 12-year-old patients from unknown genders, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was mentioned that ''totally perfect patients were now in their beds, too tired to went to school '' (disability). No further information was cited. The relatedness between disability and vaccination with GARDASIL was not provided. The event of disability was assessed as serious. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830.
Patient received her yearly flu vaccination at one of our mobile vaccination clinics. We were unaware she had already received her 22-23 yearly flu vaccination from pharmacy until we tried to bill for the vaccination. Patient did not notify us she had already received a flu vaccination. No none adverse events at this time.
pt recvd vax; welts on body, itching day p/ immun; achiness devel 3 days later 20dec93;
1 week after receiving the vaccine, what I believe to be a gout flare started in my right foot.  The joint of my big toe became very swollen and red, painful to the touch and the rest of the front part of my foot also became swollen.  It was difficult to walk or even put pressure on it for 5 days and I treated it with ice, elevation and 600 mg ibuprofen 3X/day.  Symptoms are starting to resolve , but the joint is still swollen and red, though the pain is subsiding.  I am able to walk with a normal gait, though there is still stiffness and some pain.
On approximately 07/15/2022, in the morning, my right hand started swelling, very itchy, and a rash under the skin like a sunburn. My eye swelled shut, my earlobes, my feet. I went to my primary and they referred me to an allergist. He prescribed an Epipen and Allegra.  I was doing well until yesterday and I started to have the sensation again, but not as bad as before.
Pain at injection site - with 4 inch radius lymphadenopathy. Lt. axillary area fine, blanching, macular rash on abdomen. Burning Lt shoulder area.
After1st dose December 22, 2020. I've had an on going headache since morning of the December 23, 2020.  After 2nd dose January 08, 2021 , (Pfizer EK417, also left arm IM) occasionally light headed with ongoing headache. I will find a new PCP, my insurance has changed.
1 day after second dose: Swollen left armpit; 1 day after second dose: Dizziness and Light headedness; 1 day after second dose: Nausea; 1 day after second dose: Weakness; 1 day after second dose: Fatigue; Dose 1: 28Aug2021; Dose 2: 06Oct2021; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Oct2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma allergies. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), cetirizine hydrochloride (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and unspecified prenatal vitamins for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Aug2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 07Oct2021, 1 day after the second dose, the patient experienced swollen left armpit, dizziness, light headedness, nausea, weakness and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen left armpit, dizziness, light headedness, nausea weakness and fatigue was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
right shoulder became swollen, reddened, warm and itchy within 12 hours of administration.  Reaction continued x 48 hours.
Patient states weakness and slight pain in injection side arm.  Patient states can not lift arm as high as before vaccine.
Full body rash - which started on my back, stomach and chest - spread to my legs, arms, neck and scalp.