chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Nurse refers to a patient of unknown age. The nurse reported that the patient the 1st dose of RECOMBIVAX HB and VAQTA on 21-DEC-2012 and the second dose of RECOMBIVAX HB on 18-FEB-2013. The patient was in the office about to receive their 3rd dose of RECOMBIVAX HB and their 2nd dose of VAQTA on 17-JUN-2013.No adverse effect reported. This is one of the two reports from the same source. Additional information has been requested.
Following dose #1 of Engerix-B pt exp lightheadedness/dizziness & foggyness on 15MAY92; then exp pain in rt arm & pain in both legs in the AM 16MAY92; pt seen in ER;
21 year old male with chief complaint of pruritic rash encompassing upper body x1 day after receiving JEV vaccine. Rash red, splotchy, raised. Patient noticed rash when we went to take a shower. Does not report any known allergies. Denies fevers, night sweats, and chills. No medication taken by patient for this issue.
redness, warmth, and swelling to her injection site; redness to her injection site; warmth to her injection site; swelling to her injection site; itching to her injection site; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 73 years old female patient who experienced redness, warmth, and swelling to her injection site (vaccination site inflammation), itching to her injection site (vaccination site pruritus), redness to her injection site (vaccination site erythema), warmth to her injection site (vaccination site warmth) and swelling to her injection site (vaccination site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient was postmenopausal.   On 21-Oct-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: U6512AA, expiry date: 23-Oct-2021) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious redness, warmth, and swelling to her injection site (vaccination site inflammation), itching to her injection site (vaccination site pruritus), redness to her injection site (vaccination site erythema), warmth to her injection site (vaccination site warmth) and swelling to her injection site (vaccination site swelling) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Lab data was not reported.  Final diagnosis was itching to her injection site and redness, warmth, and swelling to her injection site.   The patient was treated with 10 mg/mL triamcinolone intramuscular in the left hip and a prescription for prednisone 20 mg by mouth daily for 7 days.  The patient outcome was reported as unknown for all the events.
Patient received 2nd dose only 11 days after 1st dose. Patient with developmental delays' guardian contacted twice by phone stating the patient had missed his second dose and he had his 1st dose in February.  The scheduler put him on the for 3/30. When they arrived, the information desk asked for the vaccine card to verify his 1st dose information but the guardian said it was lost.  They patient received the 2nd shot.  During the observation period the infection control nurse asked for the card as well to update the the date, lot of the vaccine.  She searched the website and did not find the patient, but found the patient had been in the hospital computer system for 3/19 for the COVID vaccine.  Pharmacy also confirmed the form that documented the patient received the dose on 3/19. The guardian stated the patient was not here that day but was here in February but all of the documents that were filled out er from 3/19 not in February.  The  ( documentation system had not been accessible during this time due to internet issues). The Infection control nurse showed the documentation to the guardian to show the patient had received the 1st dose 3/19 and that the second dose was way to early. The information on side effects was reviewed again at this time.   Unsure of any ADRs at this time.
Following the vax, the pt developed arthralgias and arthritis. As of 10/26/00, the outcome of the events is unknown.
long term POTS, CFS, PEM, dysautonomia, MCAS, vagas nerve disfunction, nausea.  All started within a couple weeks of the vaccine and symptoms increased in severity until bedridden most days.  Treatment included vagus nerve therapy, neuro therapy, low histamine diet, H1 and H2 antihistamines, rest, gammacore therapy.  After 6 months of treatment, was reasonably high functioning again, however still has residual affects like occasional POTS and histamine intolerance.  ER trip in late 2021 for stroke like symptoms, diagnosed as
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who received two doses of 0.5 mL of vaccine FLUBLOK QIV lot QFAA1810, expiry date: 30-06-19 via intramuscular route in the left deltoid on 01-Oct-2018 and 22-Oct-2018 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Extra dose administered. It was reported that inadvertently gave a second dose of FLUBLOK QUADRIVALENT to the same patient. First dose was administered on 01-Oct-2018 and the second dose was administered on 22-Oct-2018. It was a case of actual medication error due to Extra dose administered. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Donor stated she experienced generalized muscle tenderness one day following and 1 day after (NAIR) hair removal to both upper ext noticed rash to immunization arm 2 days after shot. Visualized by staff on 9/5/06.
Developed rash from head to toe. Went to MD was treated with ZYRTEC and BENADRYL. Attempts to call mother to check on rash or get name of MD go answered.
p/vax pt exp croupy cough w/o stridor, no wheeze;c/o chest tightness, air hunger was conscious of breathing, felt like could not fully expand chest & felt hot then cold;
I spent over one week in the hospital with Acidosis, nausea, vomiting, diarrhea, dehydration and severe fatigue. Prior to this I spent one week on my couch with the same symptoms. I was sicker than I had ever been.
Vitals Signs temp: 99.1,B/P 124/82,Immunizations administered, Student reported little breakfast. Student given juice/Candy to elevate blood glucose level. Student was breathing deeply and rapidly. School Nurse stated unusual behavior for student. Feet were elevated. Student ambulated to School nurse office, Parents notified. Ambulanced called Rapid breathing persist. When Ambulance arrived. EPI Pen administered.
Vaccine administered beyond use date; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 37 years and 7 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment information was provided by the reporter.
1st dose on 10-January-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The pharmacist reported that the patient did not received the second dose of Shingrix. The reporter wanted to know if the patient had to restart the series. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Approximately 12 hours after injection, I woke up during the night and had a weird feeling like restless leg syndrome and felt nauseous.  I got up to go to the bathroom and passed out.  My husband helped me to the bed and got me some orange juice.  I then experienced extreme uncontrollable shaking for about 10 minutes.   The next day, I had a sore arm where the vaccine was administered.  I have only had one flu vaccine in my whole life.  I am not allergic to anything that I know about.  I have had problems with passing out and have been diagnosed with vasovagal syncope.   However, I have not passed out in over 10 years.
Patient received the pediatric Pfizer (PEDS) Covid-19 vaccine and pediatric dose (0.2 mL) instead of adult Pfizer vaccine and dose. RN administered vaccination before entering documentation into patient record and, thus, did not catch the error.
Sustained back injury approximately 6 wks before receiving 4th anthrax. Worsening pain, weakness after receiving anthrax.  No improvement with PT.  Some improvement with NSAIDs, chiropractor.
pt recv vax JUN96 & FEB97 revealed a lack of seroconversion;
Arm soreness radiating to joints and neck Feverish Chills Insomnia Generalized weakness GI upset
Light-headedness, tingling of lips after vaccination; Gave liquid Benadryl 25 mg and observed.
Really dry mouth; chills; bodyaches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Really dry mouth), CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Mar-2021. Concurrent medical conditions included Thyroid disorder NOS (1990's) and High cholesterol (1990's). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFEXOR XL) for Anxiety, LOVASTATIN for Cholesterol, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Routine health maintenance, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021 at 8:00 AM, the patient experienced CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever). On an unknown date, the patient experienced DRY MOUTH (Really dry mouth). On 10-Jul-2021, CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) had resolved. At the time of the report, DRY MOUTH (Really dry mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up information included updating patient information, medical history, dose detail, and newevents.
Severe flu like symptoms. Woke up with body so sore it was hard to get out of bed. Severe chills. Fever. Headache.  Vomited about 16 hours after shot. Slept for 19 hours out of 24 hours. Got shot on 4/12/21 at 11:20 AM, on 4/14/21 woke up to a sweaty shirt, fever broke. When taking a shower the same morning, I found a baseball/softball size lump between my breast and armpit on my right side. The same side as my shot. My right arm also had redness, and a small bump where the shot was given. It was extremely sore.  Currently it is 4/16/21 and although the symptoms are getting progressively better, and significantly mild, I am still sore, have low energy and the lump is still there.  I did not have any reaction other than a slightly sore arm to the first dose.
After the second shot, She experienced a sharp pain at the injection site as well as numbness throughout her entire arm to fingertips. It began to get more intense. She took tylenol and other over the counter pain medication without any improvement. She went to the emergency room on 7/5/2021 and urgent care 7/6/2021 due to unbearable pain and numbness. She was prescribed gabapentin 300mg which she takes 2 capsules 3x daily but seems to now built up a tolerance because it is only effective for about a few hours. She is not able to work or have any normalcy. We do not know what else to do. She needs assistance.
p/vax pt had sz;pt found on back twitching & eyes were rolled back in head;pt came out of sz & was OK rest of noc;pt taken to MD next day & bilat ear infect discovered;
Information has been received from a registered nurse concerning a 4 year old male with no known allergies or pertinent medical history who on 09-MAY-2007 was inadvertently vaccinated SC with a dose of Zostavax (lot # 656606/0033U) instead of MMR. Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown) and PREVNAR. Unspecified medical attention was sought. The patient had no symptoms or adverse effects. There were no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 6/14/2007. Additional information has been received from the registered nurse who stated that the error occurred because of the bottles of the vaccines were kept in the same place and they looked similar . It was reported that now they store vaccines seperately to prevent the product confustion. There were no adverse event reported. No fruther information is expected. This is one of several reports form the same source.
This is an initial report of an AE, received on 11Oct2016, for Protein Sciences Flublok.  Subject, a female, received the influenza vaccine on 06Oct2016. On an unknown date after receiving the influenza vaccine, the subject experienced injection site erythema. The subject posted a photo of the injection site erythema and asked whether it was normal. The subject was unsure as to whether she got the regular flu vaccine or Flublok. Five days after the vaccination, the subject's injection site was still red, but was not as bad as before.  At the time of the report, the event of injection site erythema was not resolved. Medical or surgical history and concomitant medications were not reported.
My child's oxygen regressed to 86 percent on his stats, his temperature went up to 104.0, he was screaming without stopping for 4 hours straight, and this all started within a few hours of him getting a full dose of vaccines.
52 y/o female, with past medical history of headaches, who presents with throat tightness and some discomfort swallowing post vaccination administration. Patient states that she is allergic to PCN. This is the patient?s 2nd vaccination which was applied to the left deltoid. NP and Paramedics at the patient?s side. Patient vitals within normal limits (85 HR, 100% SPO2, 110/72 BP, Resp 10). Patient provided with a bottle of water and 25mg Benadryl PO administered x1. It was explained to patient that if symptoms do not improve with Benadryl then we would have to administer EPI and seek further emergent evaluation. Patient agreed. Patient with resolution of symptoms within 25 minutes of medication administration. Patient discharged home in stable condition.
About 2 weeks after the first dose I noticed stomach pain and stomach noise.  More frequent BM, and stomach/ lower abdominal pain.   Saw Doctor on 2/3/21  Thought this was a stomach bug and took antibiotics (Ciprofloxacin and Metronidazole), this did not work and made it worse 2 weeks after leading to heavy diarrhea.   Saw my primary care doctor 3/29/21. Ran tests and positive for C. Diff.   10 days on Vancomycin (finished 4/18/21) This seemed to help all C. Diff related symptoms, but now back to original lower left abdominal pain and stomach noises/ rumbling.
Symptoms began 6 hours after shot abruptly. Fever of 104, heart rate over 120, blood pressure spikes, headache, trembling, severe body pains and shooting pain, dizziness, lightheaded essential, short of breathe. All symptoms persisted for over 12 hours, but the fever broke with aspirin, and Tylenol given by the Emergency Room at 4am the following morning. Pain was too great to walk or sleep until 8am after the fever broke. The following day I was still sick with a mild fever, headache, and tachycardia that wasn't as high.
Information has been received on 09-FEB-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 19-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-MAR-2017, the patient was treated in an emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and post-herpetic neuralgia. The patient has been prescribed prednisone, FAMVIR and DILAUDID for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
swollen lymph nodes; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. Medical history included HAE hereditary edema. Concomitant medication included steroids. The patient received the first dose of the PFIZER-BIONTECH on 23Mar2021 within 8 minutes her arm started swelling and it progressed to her neck, chest and head, the swelling persist. On 24Mar2021, she went to ER they treated her first with Benadryl and anti-inflammatory drugs and then with steroids, she's been taking steroids for a month; she was diagnosed with HAE hereditary edema. She also experienced swollen lymph nodes on unspecified date. Patient stated she hadn't had a facial surgery and the swelling persist and it's been a month, she hasn't received the second dose of the vaccine. Patient would like to know when this was expected to go away and how protected she was from the first dose of the vaccine because she's also taking steroids. The outcome of the events was unknown. This report was assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ten minutes after received the vaccine the patient reported generalized itching, headache, dizziness, and throatfullness. Patient spoke easily but stated 'I have itching all over and funny feeling in my throat' and was noted to be scratching arms, neck, legs, and middle while answering questions. No rash noted. Patient was taken to the ED (within same building) and given oral Benadryl 25mg at 1507 and acetaminophen 100mg orally at 1615. The patient was then discharged from the ED at 1639. At 1638 the patient reported that her itching was completely relieved.
Pt presented to PCP 1 wk after she received MMR and VARIVAX in R deltoid with 3-4 cm abscess.