chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 12/9/03 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 12/7/03. On 12/7/03, the vaccinee inadvertently received 0.5ml Fluvirin IM. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 4/5/04: Follow up information received from a health care professional indicated that a 19 month old female vaccinee inadvertently received 0.25ml Fluvirin on 12/7/03 and 1/12/04. No adverse events have been reported to date. No follow up pending. All information received.
This spontaneous report as received from a physician refers to a 20 years old female patient with no pertinent medical history, allergic to cats and allergic to pollens, who wasn't pregnant at the time of the report. On 07-MAY-2010 the patient was vaccinated with GARDASIL, (dose route and site of administration was not reported). Lot number: 1337Y, exp. date 29-JUN-2012 is an invalid lot number for GARDASIL. Patient's concomitant therapy included "oral contraceptive". In April 2012 (one year ago) the patient experienced difficulty concentrating, constipation, bloating, acne and mental fogginess. No lab diagnostics studies were performed. There was no treatment provided. The outcome was reported as not recovered. The patient sought medical attention: she saw the physician. The relatedness between adverse events and GARDASIL was not reported. Additional information has been requested.
I started with a sore throat and fever of around 102 F. Managed that with Tylenol. I also had a lot of mucus and drainage. I got an at home test and it came out positive. Doctor said just stay home and treat the symptoms. I was out of work from 1/10-1/15 due to illness. I received Johnson & Johnson for my booster but had Moderna for my first 2 doses.
Face Swelling, lips swelling, felt like inside of mouth was thickening.  Called doctors office and spoke to oncall doctor. He recommended to take antihistamine.  On way home -stopped at gas station and got Benadryl.   Took Benadryl twice Saturday and Sunday. Had cold chills and sweating  Sunday night.  Stomach pain and diarrhea Monday.
constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes toward right breast and up to the right side on neck.  pretty painful.
Extreme dizziness. Vision problem. Muscle weakness. Aching joints. Unable to walk, drive, go upstairs or down due to muscle pain, weakness. Today is May 17th this is the first day since 5/7/18. Had shingles 8/26/16 thru 3/2017 - residual nerve pain to this day. Had the original shingles shot may of 2017 - no reaction at all. Today is 5/25/18 this is the first day I have felt as I did before I had the SHINGRIX shot.
Information has been received from a physician concerning a 17 year old female who on 11-Mar-2008 was vaccinated with the first dose of GARDASIL (lot # 659182/1757U). There was no concomitant medication. On 11-MAR-2008 within 15 minutes of sitting after the vaccination, she became pale and started to sweat for 2 to 3 minutes. It was reported that the patient is an athlete and had practice prior to vaccination. The patient's blood pressure and heart rate were taken yielding normal results. The patient recovered on 11-MAR-2008. Additional information has been requested.
Patient had low grade fever and mild flu like symptoms achy and runny nose fatigue starting 4 hours after getting the shot and lasted 24 hours then 3 days post shot developed rash on left side under breast and armpit and back that was painful burning and stinging sensations as of 12/15 has mostly resolved still slight nerve pain.
Vaccination received 8:15PM 4/13/22 at pharmacy.  Onset of symptoms at 10:30PM  ? Onset of pronounced fatigue and mild soreness at injection site. Went to bed with a mild headache.  4/14/22: Pt tested positive for COVID-19 this day. Pain at injection site. Woke with nausea, diarrhea, post nasal drip and sinus congestion, moderate headache; severe low back pain, diffuse joint pain, and muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, profound fatigue, very cold with chills, temp 97.3.   4/15/22: Pain at injection site. Restlessness, nausea, headache and chills resolved. Diarrhea, post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 8/10. Periodic tachycardia and sharp chest pains, very tired.  4/16/22: Soreness at injection site. Restlessness, nausea, headache, chills, diarrhea, tachycardia and sharp chest pains resolved. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 3/10 on VAS. Still very tired.  4/17/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 2/10 on VAS. Still very tired.  4/18/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; fatigue, low back pain, diffuse joint pain, and muscle aches resolved.    4/19/22: All symptoms resolved. No use of Bactroban.
Report number A0375266A describes arthritic type condition of joints in a 57 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings. The personal injury claim of April 2002 noted the injury sustained was arthritic type condition of joints; vision problems which occurred in July 2000. The claim classified this injury as a permanent injury. The claim denied that hospitalization or surgery were required for this injury. As of 19 July 2002, the outcome of the adverse events was unknown. The adverse event of arthritic type condition of joints is labeled per the USPI. The adverse event did not meet ICH serious criteria, but is being submitted as an expedited report by special FDA requests per the June 28, 2000 letter.
got sick; Initial information received on 08-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.   This case involves Adult and unknown gender patient who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route in unknown administration site (dose, formulation, strength, lot number and expiry date not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I had one. Then I got sick as a dog that year"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
I got the shot and before I went to bed I started getting stomach pain, shivers, headache. Was up on and off throughout the night but I started feeling better next evening.
This is a spontaneous report from a contactable consumer reporting for herself on information received by Pfizer from Merck (manufacturer control number 1-13211237659). A female patient of unspecified ate and ethnicity received PREVNAR13, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced high fever, chills for 6 weeks and developed infection in her nose with the "same strain". Outcome of the reported events was unknown at the time of this report.
Had hives approximately 12 hrs after receiving 1st dose Hep B and Td. Benadryl given. Pt had Dr. visit on 6/17/2004.
PATIENT STATED THAT AFTER THE SHOT HER ARM WAS HURTING AND SHE WORKS AT A ORTHOPEDIC OFFICE AND WAS TOLD BY THE PHYSICIAN THAT IT IS DUE TO THE PLACE OF ADMINISTRATION
Redness and swelling on the right arm, itching on arm and pain at site of injection.  Dizziness or disoriented feeling, overall. Headache persisting since receiving vaccine (responds to acetaminophen),  Achiness in all her major joints.
Per patient report: Hives on face, temp 100F, body aches, runny nose, redness and pain at site x 3 days after injection.
I saw an Oral Surgeon in April of 2021 and he told me I had persistent Atrial Fibrillation. I have had occasional Atrial Fibrillation. I had noticed some issues in December of 2020 that I was having trouble breathing when I was exercising. I went to see my Cardiologist and I was given Cardioversion 06/01/2021 due to the Atrial Fibrillation. I started to have some shortness of breath again in nine days. I was diagnosed with a Mitral Valve problem by TEE.  I get out of breath very quickly and if there is no change with medication then I will have another Cardioversion.
an expired ActHIB vaccine was given with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp (practice manager). number: 01518653.  This case involves patient of unspecified demographics to whom expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Mar-2023, the patient received expired suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection at (unknown: strength, dose, lot number, route, administration site) for immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that "the caller states that she is a practice manager and an expired ActHIB vaccine was given this morning and she would like to know if the patient needs to be revaccinated."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Per the patient she felt flushing in face, difficulty swallowing, chest tightness, upset stomach and numbness in neck. These symptoms occurred approximately 1-2 minutes post administration and resolved approximately 5 minutes after they began.
Infromtion has been received from a nurse practitioner concerning a 36 month old white male who on 15-MAR-2004 at 11:15 am was vaccinated in the left leg with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 643955/1083M). Concomitant vaccination that day at 11:15 am included a first dose in the right leg of varicella virus vaccine live (VARIVAX) (lot # 644796/0336N). There was no illness at the time of vaccination. On 06-APR-2006 the patient presented to the physicians office with severely enlarged parotid glands bilaterally, 3- tonsiller, hypertrophy, fever. He initially responded to rocephin IM then symptoms recurred 5 days later. The fever resolved with cefdinir (OMNICEF) x5d. The tonsil and gland enlargement persisted. The nurse practitioner believed that the patient had mumps but no diagnostic tests were performed. No laboratory tests were performed. In May 2006 the patient  recovered. There was no product quality complaint involved. Additional information is not expected.
Red warm, swelling at injection site. Started 1 day after injection. Also fever to 102 - 103 degrees orally day after inj. No fever today. Eight, induated, warm 7 X 4 cm area Rt deltoid.
Immediately after injection, I had tingling in my left arm and hand. That night, I had tingling and pins and needles throughout my entire body. The next day on 9/11 and getting progressively worse on 9/12, I had rapid heart beat and chest pains, shortness of breath , a severe headache, fatigue, nausea, diarrhea, cramping, extreme runny nose, congestion, sinus pressure, body aches, weakness, and shooting pains throughout my body. I had strange pains in my tounge and lips. I went to urgent care on 9/12 and they said my heart rate was high. They said they have seen many terrible side effects similar to mine and to take Tylenol and drink water and follow up with primary care doctor. My symptoms continued through 9/13 and 9/14 and some began subsiding. However, I still have chest pressure and pain, rapid heart beat and palpitations, and shortness of breath. I also still have fatigue and headaches. I am terrified about my heart because heart disease runs in my family. I am following up with my primary care doctor tomorrow, 9/17. I was mandated to get the vaccine by my work.
1st dose was administered in 2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th December 2021).   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: 14-Jul-2022 Reporter's Comments: The reporter stated that at the time of the reporting, the second dose of the Shingrix vaccine was not yet administered to the patient and asked for guidance on how to proceed. The reporter consented to follow up. Additional Supportive Information: GSK Receipt Date: 14-Jul-2022 Reporter's Comments: The reporter stated that at the time of the reporting, the second dose of the Shingrix vaccine was not yet administered to the patient and asked for guidance on how to proceed. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
As has happened with previous vaccinations in both patient and her older sister, she displayed a dramatic behavior change the day following her vaccinations and everyday since. She is extremely irritable, does not enjoy regular activities, cries and screams with little or no provocation and is altogether different from her usual self. While this has happened before, and also with her older sister, this is the worst episode we've experienced yet.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unspecified date, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 (lot # K004930 and expiry date: 16-MAR-2015, reported as 06-MAR-2015) after the labeled expiration date. No adverse effects reported. No product quality complaint was reported for PNEUMOVAX 23. Additional information has been requested.
Swollen lymph nodes in neck. Very painful; Sore throat on same side as swollen nodes.; Swollen lymph nodes in neck; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib (Atrial fibrillation). 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medications included rivaroxaban (XARELTO) and nebivolol hydrochloride (BYSTOLIC), both for an unknown indication from an unknown dates 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 right arm on 06Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 08:00, the patient experienced swollen lymph nodes in neck, very painful. Sore throat on same side as swollen nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events swollen lymph nodes in neck, very painful, sore throat on same side as swollen nodes were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient felt lightheaded immediately after shot.  Continued to sit.  Feet was propped up and after cool pad and water began to feel better and was able to walk out of the store with assistance.
Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED.  He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology.  He was found to have positive SIRS criteria and elevated LA.  He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)
A report has been received from a Pharmacist concerning a subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that patient experienced entire dose of FLUMIST Quadrivalent entered in one nostril on an unknown date. The outcome of the event of entire dose of FLUMIST Quadrivalent administered in one nostril is unknown. The report was considered to be non-serious.
Patient had swelling and redness on arm near injection site and felt fatigued. She is using ice and naproxen for the arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Inflammatory arthritis" (unspecified if ongoing); "Pernicious anemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 29Nov2022 till 04Dec2022. Patient had other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had loss of appetite, vomiting, pain in R flank and R abdomen and excessive thirst beginning on 12/29/03. Symptoms worsened so admitted to hospital from 12/31/03 to 1/4/04. Diagnosed with diabetes insipidus and was told illness was due to YF vaccine. States is mostly recovered, but still is not retaining as much fluid as usual.
Had high fever 102.8 for 3 days (7 days after the vaccination) Began body rash 9 days after vaccination and still has the rash.  Took to ER and they gave him a steriod to help with rash but did not.
9/6/21 PMH of Phelan-McDermid Syndrome (22q13 deletion), and Pica (which she eats her hair) who presented for 3-4 week hx  of vomiting and diarrhea.  She was diagnosed with COVID infection on September 2, 2021
Became very fussy all night, elevated temperature started at 10PM 11/8/02 and lasted all next day and fussy but not as bad as Friday night.
Pt experienced vomiting lasting for 4 days, seizures lasting for 1 day, experienced an unusual cry, fussiness lasting 4 days, visual disturbance lasting 1 day. The pt was subsequently hospitalized. Discharge summary dx: subdural hemtomas bilaterlly, seizures, neurological & developmental delay
My joints, in my fingers and toes are extremely painful when I open or stretch my hands and toes, In the morning it is painful the most when opening my hands.  My right ankle continues to swell and It gives out when walking.  My left arm muscle gives out quite a bit and I have a very sharp pain that comes and goes all the way  down the middle of my left arm.   My brain is definitely more foggy and I seem to forget things more often.
Localized chest pain on the left side of my sternum below the ribcage, beginning Sunday (8/29).  Pain has continually got worse until Wednesday (9/1), since it has been consistent, not crippling pain but always there. Went to Urgent Care on Tuesday (8/31) vitals and EKG taken, nothing present out of the ordinary. Recommendation to visit General Practicioner and possibly cardiologist.  Shortness of breath began Wednesday (9/1) and has remained typically based on activity level. On Friday (9/3) severe shortness of breath and chest pain after walking from car to house after work combined with feeling weak, shaky and dizzy. Went to general practitioner, vitals taken and everything was normal. He advised that this appears to be pericarditis and recommended a visit to a cardiologist for Tuesday (9/7). This is being filled out on Monday (9/6) therefore no results from visit yet. No signs of improvement at this point, fear of permanent damage exists and will be updated following cardiologist appointment, along with advising of taking the second dose.
Epstein Barr virus resulting in ER visit. 1978 diagnosed with Hodgkins Lymphoma. 1979 Remission after MOPP. 1980 shingles. 3 hospitalizations for bacterial pneumonia. 2 episodes of mono. impaired immune functioning with autoimmune disorder. Early onset menopause, completed by age 39.