chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flublok qiv that expired on 14Jun2023 was administered to a patient on 19Jun2023 with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] that expired on 14-Jun-2023 was administered to a patient on 19-Jun-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jun-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrivalent recombinant vaccine (formulation; lot number) (strength: standard; expiry date: 14-Jun-2023) via intramuscular route in the left deltoid for Immunization. Information regarding batch number was requested in the case.  On 19-Jun-2023 the patient was administered flublok qiv that expired on 14-Jun-2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Medical assistant asks if there is any extension on the expiration date?"   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
This spontaneous report was received from a pharmacist and refers to a 16 year old patient of unknown gender. On 28-JUN-2017, the patient received an expired GARDASIL (lot # K016966, expiration date: 10-MAY-2017). No adverse effects were reported. Additional information has been requested.
Vertigo and dizziness immediately following second dose. Headaches, fatigue, and mild joint pain occured 3-4 days after second dose. Two weeks after second dose symptoms have not subsided.
This case was reported in a literature article and described the occurrence of pneumonia in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with Influenza vaccine (manufacturer unspecified), MMR vaccine (non-gsk) and varicella virus vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 20 days after vaccination with Influenza vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced pneumonia. 56 days after vaccination with Influenza vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced upper respiratory infection and fever. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. According to the Modified WHO Causality Criteria, pneumonia was unlikely related to vaccination with MMR and varicella vaccine. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Information has been received through the pregnancy registry from a physician concerning her sister-in-law, a 33 year old female who was vaccinated with varicella virus vaccine live. Shortly thereafter, the pt was found to have been 2 weeks pregnant at the time of vaccination. Follow-up was received which indicated the pt had a 1st trimester elective abortion. No medical indication was reported; the decision was personal. No further information is available.  Follow up on 06/29/2001: "Patient date of birth, adverse event onset date/time, lot # for vaccine 1, vaccine administration date/time is not provided."
Flare up of reactive arthritis after the Pfizer booster shot.    June 2020, I had a hysterectomy which resulted in a gram negative infection and reactive arthritis (diagnosed and treated by a rheumatologist). I had not had any residual reactive arthritis joint pain in the past year. The day after my booster, my joints began to ache that had previously had the reactive arthritis  (ankles, shoulders, knees, wrists, toes). I am 7 days post booster and they still ache at a pain level of 2-3.
more numbness in their body after the second COVID-19 vaccine; This is a spontaneous report received from a contactable other non-HCP (healthcare professional). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced numbness in their limbs. On an unspecified date the patient experienced more numbness in their body after the second COVID-19 vaccine, which was serious for hospitalization. One of the reporter's friends was a primary care doctor, and the doctor saw the same type of reaction that the reporter had, in another patient. The caller's friend, who was a doctor, mentioned someone that had numbness in their limbs after receiving the first COVID-19 vaccine. When this person had the second COVID-19 vaccine they had more numbness in their body and now they were hospitalized. That person was having a bad reaction. The reporter did not know anything else about this patient. The clinical outcome of the event more numbness in their body after the second COVID-19 vaccine was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Friday evening (Feb.5th) after taking off my socks saw I had a dark red rash around my ankles.  It did not itch much.  The next day on Saturday I had more red spots but not quite the same as around my ankles.  More up my legs to my knees.  This morning (Sunday Feb 7th) I now have more spots on my arms.  These spots are not like the dark reds ones around my ankles.  I also have a spot on my face.  I went to the Urgent Care in my area and the opinion of the doctor on call these spots may be related to my vaccine even though it has been 2 and 1/2 weeks since I had the covid  vaccine.  Up until this eposide I have not had any reaction to the vaccine.  They suggested  I contact you with this information.  I was given a Medrol Dose Pak for the rash.  The doctor was not sure the vaccine was the cause of my rash. I would appreciate if someone would contact me and let me know if I should not take my next vaccine which is scheduled for Feb.10 at 9:45 AM.
Patient presented back to pharmacy with a swollen, red, hot spot on arm. I told the patient to put ice on it and take ibuprofen and I would call her to follow up.
itching, swelling at site. Lymph nodes on the left were swollen. Bruising about 3 inches in diameter.
Within 3 hours of injection experienced extreme weakness and  muscle soreness of left arm; headache; nausea; extreme fatigue.; symptoms continued through the night and begin to subside somewhat around 12 pm on the next day (4/27/2019).  Took  400 mg Advil at onset of symptoms  and received some relief.  At night took 200 mg Tylenol and 200 mg of Tylenol PM, which did not give a lot of relief.   On the morning of 04/27/2019, I took another 400 mg of Advil and started to feel better around noon on that day.  Advil was much more effective than Tylenol.  Twenty four hours after the injection, still having muscle soreness and weakness of left arm.
Approx 3-4 hrs p/pt recvd vax began screaming & was inconsolably for 3-4 hrs;
Information has been received from a registered nurse referring to two patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot# K025002 and expiration date 20-JUL-2017, strength, dose and route unknown). NO adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Around 5:00-5:30 PM (about 2 to 2.5 hours after the vaccination), I started to feel a bit tired.  I took Tylenol, beginning around 5:00 PM.   By 8:00, I was feeling tired enough that I went to bed early.  By 9:00, I had terrible chills and body aches throughout my body.   The aches were worse in my chest / torso -- maybe from so much shaking.  I did not watch any of the men's championship game that night.  I also felt nauseous but I seemed to lack the strength to vomit.  I can not remember a time when I had so much physical pain in my life.  My hands felt numb / tingling.  I tried to drink some ginger ale but drinking was difficult.  Although I was aware that I was breathing and my heart was beating, I thought that I might die.  The terrible pain continued for a few hours.  Around 10:30 PM, the pain dissipated.  However, after about 10 minutes of relief, the pain returned, perhaps worse than before.  At around 11:30, my wife came to bed.  She suggested that I try relaxing Yoga breathing.   I did that and the pain stopped and I fell asleep.   The next day, I woke up with a typical headache and took more Tylenol.  I continued to improve the remainder of the day.
2-3 hrs after vaccines given, mom noted pt's left leg very swollen from site of injections down to slightly below knee. Pt unable to move leg, redness extended from site to knee. Febrile and irritable lasting all noc. Brought into Dr's office. Swelling slightly decreased, still not moving left leg, redness gone. Febrile and irritable still. MD order Motrin 90mg every 6-8hrs and follow up 6/23/06.
Four year old was given a pediatric dose of Pfizer vaccine (0.2ml). Pt did not have any reaction and reported was completely healthy and fine on a follow-up call several days later.
Approx. 2 hours, post vax, pt got fever of 106F which continued 3 days. Approx. 24 hours, post vax, he began having seizures and pauses in breathing (2 episodes).
Pt vaccinated with Influenza developed nausea, headache, swelling in eyes & face, fever & chills. Treated w/Benadryl & Prednisone.
Very fatigue, sore arm, body aches, body chills, fever, headache, brain fog
no adverse effects reported; one was administered intramuscular; Extra dose administered; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 19-JUN-2019, the patient received two separate doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one intramuscularly and the other one subcutaneously (dose, strength, dose number, site of administration, lot # and expiration date were not reported) for prophylaxis. The doses were reconstituted with sterile diluent. No adverse effects were reported.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Chills, Fever over 102, Vomiting, Dizziness, Throbbing headache
Moderna 2nd dose on 4/08/2021 Right side top chest tingles, feels like a shock or pins shaking in my top chest area, feels numb like and possible nerve damage.
PT. was given the incorrect medication the second dose of the covid vaccine. She questioned the nurse after administration, when the patient returned home she got a call from the facility stating they accidentally had given her the wrong vaccine (pfzier instead of moderna). Ever since the Pfzier shot she has developed: numbness and tingling in her head. Pressure and swelling in her head, Numbness and tingling that travels from her head down her shoulders. She has experienced severe nose bleeds that last for hours at a time. And had required emergency room visits. She even had a blood clot come out of her nose. She has been severely congested for quite some time, to the point she now requires surgery to remove a possible blockage/clot- unsure of what is causing the sinus issues - she now requires surgery 10/6/2021 (prior to the vaccine she had NOT had these issues)- but now after receiving the vaccine she has had non-stop complications. They are doing surgery to figure out what is causing the sinus issue.
Report 20010203732 described elevated bilirubin in a 33 year old male who received hep B vaccine (brand unspecified). This report was received from the vaccinee's wife and has not been verified by a physician or other health care professional. The vaccinee's allergies, and medical history were not specified. In August 2000, the vaccinee reportedly received an injection of hep b vaccine and a subcutaneous injection of hep a vaccine inactivated. Reportedly, the vaccinee subsequently developed an elevated bilirubin level, which he was currently. The consumer consulted a health care professional regarding the adverse event. Hep B vaccine was discontinued. As of 08/17/2001, the outcome of the adverse event was ongoing.
Patient received a dose of improperly stored MMR-II and Varivax; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316 with expiration date reported as 04-DEC-2021) 0.5 mL and improperly store varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024285 with expiration date reported as 15-JUL-2022) 0.5 mL (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Myalgia arthralgia fever (T m 102.2F) chest pain shortness of breath.
Tooth extraction; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH EXTRACTION (non-serious) with onset Mar2021, outcome "unknown", described as "Tooth extraction". Therapeutic measures were taken as a result of tooth extraction.  Additional Information: The reporter mentioned that he was a senior citizen who had already received the first dose of the vaccine 3 weeks ago (2021) and had experienced no side effects. He was scheduled to take his second dose today (date unspecified) but was calling to ask information because he had a tooth extraction 4 days ago (Mar2021) and was prescribed amoxicillin 500mg three times a day and acetaminophen (TYLENOL) 650mg extended three times a day. He was asking if there was any effect on the vaccine and any of his medications, including heart medications. He mentioned that he spoke to someone from the number and they mentioned that he should not take any ibuprofen for the vaccine but was unsure of the acetaminophen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(L) thigh hot to touch swollen & red. (R) thigh blotchy red. Hot packs, BENADRYL, Ibuprofen - Cold packs.
C/O Severe muscle aches--injection site (R deltoid), back, legs, arms, soles of feet. Took OTC MOTRIN w/o relief. No prior reaction to TD. Saw PMD on 3/23/10. Date of onset: 3/20/10. Date reported: 3/23/10. No known drug allergies or prior hx of adverse vaccine reaction.
Intense pain in the right shoulder.  Pain was more intense towards the back of the shoulder/arm.  This was two hours after the shot.  No, on 11-20-2014, I have limited range of mobility with soarness to a shooting pain.  I feel fatigued and nausea.
40% hearing loss; developed tinnitus; felt like he had the flu; chills; This case was reported by a consumer via call center representative and described the occurrence of partial hearing loss in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 1st dose of Shingrix. On 10th June 2020, 2 days after receiving Shingrix, the patient experienced influenza like illness and chills. In June 2020, the patient experienced partial hearing loss and tinnitus. On an unknown date, the outcome of the partial hearing loss was unknown and the outcome of the tinnitus was not recovered/not resolved and the outcome of the influenza like illness and chills were recovered/resolved.   It was unknown if the reporter considered the partial hearing loss, tinnitus, influenza like illness and chills to be related to Shingrix.  Additional details were reported as follows: The patient received his first dose of Shingrix vaccine and 2 days after receiving the vaccine he felt like he had flu and chills which lasted for 2 days and then resolved. After 5 to 6 days later he developed tinnitus which has not resolved.  He went to his ENT and was told that he has 40 persent hearing loss and need hearing aids.  The reporter consented to follow up.
This spontaneous report was received from a Medical Assistant concerning to a patient of unknown age and gender. Medical history, concomitant medication and concurrent conditions were not provided. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N024384, the expiration date:18-MAY-2019 (dose and route were not reported) for prophylaxis. No adverse effects reported. There was no previous temperature excursion and the call was not due the data logger. The temperature reported was 12°F with a time frame of 5 hours.
Information has been received from a health professional concerning an 18 year old female who was vaccinated with her first dose of Gardasil in another doctor's office.  Subsequently the patient experienced a heart defibulation problem.  The patient was not a patient of the health professional, but she can be contacted for more information.  Additional information has been requested.
Itchy rash around his waist; red rash around his waist; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022.  Reporter's Comments: The reporter was the wife of the patient.   The patient received his Shingrix on right arm.   The reporter stated the patient developed an itchy, red rash around his waist.   The reporter stated that her husband showed her the rash on the day of the reporting. Reporter gave consent to follow up with health care professional (HCP) (pharmacy).
I passed out within 5 minutes of receiving my booster shot. Within 1-2 minute of receiving the injection, my vision became spotty, I started sweating, and I could feel my blood pressure dropping rapidly. I stood up to ask for help from someone in the pharmacy and I collapsed/passed out. When I woke up, the pharmacist and a couple of pharmacy technicians were surrounding me, helped me put my feet up, got me some water, and waited with me for about 30 minutes until my vision returned to normal and color returned to my face/hands/etc. Some residual weakness and dizziness for the remainder of the day. Other than the original Janssen shot I received (see previously filed report), I have never had an adverse reaction to a vaccine before.
The patient developed an unspecified rash in an unspecified area; This spontaneous report was received from a registered nurse and refers to a 1-year old male patient. No information was provided regarding patient's medical history, concurrent conditions, allergies or concomitant medications.  On 07-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin(rHA), subcutaneous for prophylaxis (reported as routine injection) (lot # N027779 with expiration date on 08-AUG-2019, dose and frequency were not reported).  On the same date, the patient developed an unspecified rash in an unspecified area after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered. It was reported that patient's parents called the physician office on 10-MAY-2019 and it was also reported that patient received treatment for the adverse event.  The outcome of unspecified rash in an unspecified area was not recovered at the moment of this report.  The relatedness between the event rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration was unknown.