chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published literature article, concerning a 71 year old female pediatric nurse with frequent upper respiratory tract infections, chronic cough, COPD exacerbation and had a history of acute pneumonia, shortness of breath of 3 years duration, smoker (also reported as 40 pack year smoking history) and hospitalisation, In the early 1990's, the pt was vaccinated with pneumococcal 23v polysaccharide vaccine (details not reported). In June 2002, the pt was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. In July 2002, the pt developed bronchitis. I June 2003, the pt developed multifocal pneumonia and was hospitalized. In August 2003, the pt was vaccinated with the third dose of pneumococcal 23v polysaccharide vaccine. In December 2003, the pt developed influenza A. In Nov 2004, the pt developed Haemophilus influenza. At the time of this report, the pt was recovering from the events. The published literature article reads as follows, the pt reported that she had been given pneumococcal vaccine in the early 1990's but those details were not available. She was given a dose of 23 valent pneumococcal polysaccharide vaccine in June 2002, after her treatment for acute pneumonia was completed. At that time she was receiving a prednisone taper, dating to her hospital stay. Her dose was reduced from 10 mg/d on the day of vaccination to 5mg/d for 1 week and then 5 mg every other day for a week. Three additional episodes of bronchitis occurred between July 2002 and March 2003, each of which was treated with oral antibiotics. She was hospitalized in June 2003 with multifocal of pneumonia, again with an S pneumoniae positive sputum culture. Immunoglobulin levels (IgG 1.470 mg/dl, IgA 187 mg/dl and IgM 88 ml/dl), but specified antipneumococcal antibody levels, although greater then 1.0 ug/ml in all 12 stereotypes tested, showed little increase between pre vaccination and post vaccination titers obtained 1 month after administration of her second 23 valent pneumococcal 23v polysaccharide vaccine. An RTI in Dec 2003, diagnosed as influenza A, slowly resolved in 1 month despite the use of oseltamivir. No Nov 2004 she developed pneumonia again, confirmed by a chest radiography, and was hospitalized. Sputum Gram stain and culture showed many white blood cells and small gram neg bacilli identified with Haemophilus influenzae. In Feb 2005, the pt started monthly IV IgG replacement therapy 25g of 350 mg/kg per dose. She was without infection and did not require antibiotic therapy for any reason until May 2006, 15 months after starting replacement therapy. At that time, she was given a single outpatient antibiotic course for a mild increase in symptoms and yellow sputum. She completed that course with a prompt response to therapy and remains free of infection as of July 2006. This was the first article describing the successful use of IgG replacement therapy in an adult with documented recurrent RTI's with polysaccharide encapsulated organisms and apparent insufficient response to pneumococcal 23v polysaccharide vaccine. No further information is available.
I received my first Covid 19 (Pfizer) vaccine on April 22 and by the next day, began to experience a marked difference in the level of already-present tinnitus in my right ear. Along with the increased volume, I am also experiencing a pressure or "fullness" in that ear that was not present before the vaccine. It's been only a week, but the symptoms have not subsided yet.
Left shoulder, armpit, lateral aspect of left breast, and collar bone all achy and tender since Monday 9/27/21.
slipped on ice; tore the meniscus in left knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (slipped on ice) and MENISCUS INJURY (tore the meniscus in left knee) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee meniscectomy in March 2021.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FALL (slipped on ice) (seriousness criterion medically significant) and MENISCUS INJURY (tore the meniscus in left knee) (seriousness criterion medically significant). The patient was treated with Surgery (Left knee meniscus surgery in March 2021) for Meniscus injury. At the time of the report, FALL (slipped on ice) and MENISCUS INJURY (tore the meniscus in left knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided. Case was assessed as serious as per reported seriousness in source document.  This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the expected serious events of fall and meniscus injury. The events occurred approximately 15 days after the first dose of Spikevax. The rechallenge was negative   as the events did not recur after the second dose of the vaccine. The concurrent event of fall remains a confounder for meniscus injury. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-331173 (Patient Link).; Sender's Comments: This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the expected serious events of fall and meniscus injury. The events occurred approximately 15 days after the first dose of Spikevax. The rechallenge was negative   as the events did not recur after the second dose of the vaccine. The concurrent event of fall remains a confounder for meniscus injury. The benefit-risk relationship of Spikevax is not affected by this report.
Patient reported cold sores started on upper lip 3-4 days after shingrix, still active sores.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 10-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, anatomical location was unknown) that expired on 14-DEC-2014. Concomitant medications were unspecified by reporter. No adverse experience reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Red, swollen area (the size of a golf ball) warm to touch, left arm treated with Benadryl, Ibuprofen.
I have suffered from mild tinnitus from exposure to loud sounds, mostly pronounced in my left ear, for several years now.  About 1 week after my second dose I noticed that my tinnitus (the ringing in my ears) got significantly worse - especially in my left ear.  My perception of dynamic range for sounds was severely limited and loud sounds sounded like static and caused headaches and significant discomfort.  It is now 5/18, my second dose was 4/29 and my tinnitus is still significantly worse than before I got my shot.
This spontaneous report as received from a other health professional refers to a 12 years old female patient with no illness at the time of vaccination. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM on 30-DEC-2011 at 11:54 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received a vaccine that was stored at an improper temperature <32. There were no adverse reactions. This is one of several reports from the same source. Additional information is not expected.
Tingling and numbness starting in feet, moved up calves and thighs to bottom and pubic area over 3-4 days.  Currently waiting for nerve reaction to subside.
Recieved obituray on patient. Called pt. ER contact and she stated that she was unaware how patient died. Pt. died at home but states that pt. had been having flu-like symptoms in bed with chills after vaccination. Pt. ER contact is unaware of pt. medical history or current medications. Pt. ER contact that pt. PCP was not us but another medical facility. Called funeral home and spoke to employee and she stated that the coroner cause of death listed was acute MI. Employee stated that she does not have a certified copy of death certificate at this time.
Patient presented to pharmacy 30 days after receiving vaccine. Patient presented with a raised bump on her arm over the deltoid muscle, where she claims the vaccine was injected (this is consistent with the arm the pharmacist documented for where it was administered). Patient denies pain or itching at site of raised bump, but is irritated with the skin growth.
01/11/22: COUGH, HA, CHILLS, SOB, MUSCLE PAIN
Headache on and off for 5 days located radiatingf from the back of the eyes to the base of the skull.  Described as a naging dull ache.
She developed a raised area described as "looking like a moon" at the injection site; rash down her arm; This is a spontaneous report from a contactable consumer (reporting his daughter). A female patient of an unspecified age received first BNT162B2 (Pfizer Covid 19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 28Mar2021, as single dose for COVID-19 immunization. Patient developed a raised area described as looking like a moon at the injection site. Four days later she developed a rash down her arm. She was seen in the emergency department (ED) and was prescribed an unspecified steroid & creams. Her PCP has advised that she should receive a different brand for her second covid vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
When I arrived to the pharmacy there was a backlog of immunizations needing to be administered. So I started to process the immunizations that were pending. Because of the patients age they should  of received FluQuad and not the FluzoneHD. The issue was not caught until the insurance billing information became available.
Myalgia, Fever, NauseaVomiting, CHILLS, BODY ACHES, FEVER, HA, AND  NAUSEA Narrative:  Other Relevant History:
Patient administered expired dose of ADACEL vaccine, with no adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist and non-healthcare professional via Medical Information (Reference number- 00778177).  This case involves a 26-year-old female patient who was vaccinated with the expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 20-Sep-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5655AA and expiry date: 15-Aug-2021) via at an unknown route in the left arm for prophylactic vaccination.  It was reported "Is there any extended time that an ADACEL (306 - ADACEL) can be used beyond the expiration date? His pharmacy gave a dose of ADACEL that was expired at the time of administration".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Within couple of hours - sudden onset L ear hearing change with tinnitus.  Supine mild vertigo approximately 29 hours later
Swollen injections site, itiching and redness, very sore. Having flu like symptoms, headaches.
Fever 104 on the night of the Pediarix was administered. Treated with Tylenol PRN and cold compresses.
Tested positive for COVID on 4/22/2022. Experienced runny nose, fatigue, headache and congestion. I also noticed that my sense of smell has improved.
Received vaccine approx 4pm - the next morning mom noticed a 50 cent piece size welt at injection site. Today 7-13-11 mom states he has a large size red, warm, hard area on arm (measured 5 1/2" diameter).
fever 102; chills; body malaise; sore arm; headache; This is a spontaneous report from a non-contactable nurse. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= k9231) via an unspecified route of administration at single dose for COVID-19 immunisation. Patient had no COVID prior vaccination, no COVID tested post vaccination, no known allergies (NKA), none other medical history. The patient's concomitant medications were not reported. It was reported patient experienced adverse event: fever 102, chills, body malaise, sore arm, headache, all adverse event start date on 13Jan2021. No treatment for adverse event received. Outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
patient reported diagnosis 2/9/2020 of shingles.  Was seen at emergency room
Since my first vaccine, neck pain and every time look down neck pops. I feel like there is a pulling cord on my cervical area. Also when sleeping, I try to turn around on the bed. It is painful on neck and cervical area.
Patient complained of "big lump in my throat" watery and itchy eyes started approximately 4 hrs after vaccine was given. She's going to take BENADRYL and report to ER if needed.
From mailed correspondence received at manufacturer on 3/4/02 from a research center, it was reported that a female received an Ipol on 8/21/01. The PT developed a fever on the same day of vax. From add'l correspondence received on 12/9/02, it was reported that the 2-mt-old female PT received first dose of Ipol given SC in the right thigh, Tripedia given IM in the left thigh, Comvax given IM in the right thigh, and Prevnar given IM in the right thigh on 8/21/01. The PT did not receive any other vax's w/4 wks of vax date. The PT was seen by an MD and reportedly recovered from the event. The case is closed.
Moderna vaccine adverse affect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna vaccine adverse affect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna vaccine adverse affect). At the time of the report, VACCINATION COMPLICATION (Moderna vaccine adverse affect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided
Cellulitis of LVL (site of Dtap and IPV given 7/15/05)
This spontaneous report was received from a registered nurse refers to a 57 year old female patient. There were no drug allergies or reactions. On 10-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the right arm. Concomitant therapies included PRADAXA. On 11-SEP-2013, the patient developed 3 inch area of erythema, soreness and swelling at the injection site. Treatment rendered for the events were BENADRYL and ZYRTEC. There were  no laboratory diagnostics performed. The outcome of the events were reported as not recovered. The patient did not seek medical attention. Additional information is not expected.
Client got dizzy and lightheaded upon administration of 1st dose of Pfizer (lot FC3181). Client had similar reaction without our knowledge. Client assisted to ground by nurse. Vitals taken WNL. Abrasion noted to right outer forearm dressed. 911 called, Vitals taken multiple times with constant observation. Client given water and crackers with improvement. Client refused any further treatment and was taken home. A/O x 4 with steady gait.
Information has been received from a physician concerning a 35 month old male with eczema and allergies to peanuts and eggs, who on 27-FEB-2006 was vaccinated with a first dose in the left thigh of varicella virus vaccine live (Oka/Merck) (lot# "B08663B"). Concomitant vaccine administered on the same day included a fourth dose in the right thigh of Prevnar (Lot# B08633B). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was indicated that one week ago (approx 23-JAN-2008), the patient developed chicken pox. The patient sought medical attention at the physician's office. At the time of this report, the patient was reported to be recovering. There were no laboratory or diagnostic tests performed. A product quality complaint was not reported. Follow-up information from a health professional indicated that the patient's chickenpox was an average case. Subsequently the patient recovered. This is one of two reports from the same source. Additional information is not expected.
After second shot, both myself and my husband had a spike of fever, chills and major shaking about 11-12 hours after the shot. The shaking lasted about 30 minutes, did take ibuprofen. Fever lasted about 5-6 hours.
Narrative:  Patient reports he ate food prior to coming for vaccination. He has had stress recently d/t death of wife two weeks ago, so he has been having some hard days. After Ice pack and cold towel and water, Patient reported he is feeling better. VSS.
I had a pain in the injection site that evening till next afternoon. I was not concerned or alarmed.  HOWEVER, Sunday (Jan 31) I started itching badly on the leg on the side of injection (right side) around 4:30  there were huge dark red hive like marks all over.  In an hour it seemed to be on my arm.  I took  Benadryl (50mg).  At 10 o:clock  I went to put an pajamas and saw they were all over the left side of my arms and legs as well .  I took another dose  Benadryl , and again at 4 in the morning.  I thought it felt better in the morning but the spreading and itching was back  I notified my dr who said as long as I could breathe and swallow and my lips were not swollen I should not worry - tho he did find the reaction unusual.  He told me to take Zertec . I live alone, and have been quite concerned.  I can't find similar reactions on line.    My arms and legs are covered .  I wish someone would get in touch with me and tell me what to do.
he had a delayed reaction to MMR II, which was a temperature of 103 Fahrenheit; This spontaneous report as received from a consumer refers to a 13-month-old male patient. The patient had no pertinent medical history, drug reactions, allergies and concomitant medications.   On 04-MAR-2021, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number, expiration date, dose and route of administration were not provided) as prevention of measles, mumps, and rubella diluted in sterile diluent.   On 17-MAR-2021, the patient had a temperature of 103 Fahrenheit (fever). The patient sought medical attention. No lab diagnostics and studies were performed. No treatment was given for the event.  The outcome of fever was reported as not recovered.  The relatedness between the vaccine and fever was not reported. However, a child's pediatrician stated the child had a delayed reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), which was a temperature of 103 Fahrenheit.
Three circumscribed ulcers with white fluid (pustule?).  Symptoms for 8 days - Pt treated for r/o syphilis at DFCC.  PCN 2.4 mu - Seen at CDS r/o 4SU ? vaccinia. Referred to Dermatology.  Contact transfer.
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patient were vaccinated with improperly stored MMR II (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd vax & w/in 5 mins pt exp exacerbation of Transverse Myelitis; new numbness & inc weakness were noted; pt was treated w/ Solu Medrol;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2106, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L048854, expiration date: 31-AUG-2017, (exact dose was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effect were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reported. Additional information has been requested.
This is a non-serous case from a nurse reporting a patient experienced Lightheadedness:  after receiving FLUMIST. The reporter causality is not provided. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FLUMIST. An adult patient experienced lightheadedness 20 minutes after receiving FLUMIST. The patient's clinical outcome is unknown.  Additional information has been requested.
Became light-headed, pale, hypotensive after receiving 2nd of 3 shots. Assisted to reclining position, juice given, VS monitored.  Was allowed to ambulate 15 minutes after first becoming light-headed.  Discharged with Mom after 25 minutes.  Follow up phone call on 06/25/2008:  client was feeling fine, no further problems.  Inst. to call private provider as needed.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with 13 improperly stored doses of VARIVAX (Merck) injection (dose, lot#, route of administration and expiration date were not reported). No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Child received Td and MMR in same left arm. Next day noted to have redness and swelling. came to clinic for PPD reading and seen by nurse on 04/16/2003. Had 4 x 6 cm red, warm, swollen area left deltoid.
SEVERE BACK PAIN & SEVERE HEMATURIA RESULTED WITHIN 2 DAYS /P 1ST DOSE OF HBV-VACCINE GIVEN OF 2MAR90. 2ND INJECT GIVEN ON 8MAY90. WITHIN 2 DAYS PT C/O BACK PAIN AND HEMATURIA. PHYSICIAN FELT SYMPTOMS FROM VACCINE.
Coughing, tightness in throat, headache, hoarness, heavy phlegm production and fatigue and a fever and on Sat 10/30/2010 I went to Dr. with an Allergic Rash reaction. Dr. prescribed Methylprednisolone. Had a fever of 100.6f. Rash started to lighten within 2 hrs of taking Prednisone Flu symptoma lasted until 11/13/2010.