chrisvoncsefalvay/vaers-outcomes huggingface dataset:
80 year old man received two doses of the FLUZONE HD within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-healthcare professional and consumer/non-health care professional via Agency (Reference number- 00812846) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 72-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 17-Sep-2021 and another on 06-Oct-2021 (extra dose administered).  This case involves a 80-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 27-Sep-2021 and another on 14-Oct-2021 (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [influenza quadrival a-b high dose hv vaccine strength: high dose, drug structure dosage : 0.7ml drug interval dosage : once drug treatment duration: once, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported " 80 year old man received two doses of the FLUZONE HD. Patient received the first dose on 27-Sep-2021 and the second dose on 14-Oct-2021."  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Swollen eyelids. Claritin Reditabs given and Prelone 20 mg day PO.
(R) arm red, hot, swollen from shoulder -> elbow. Tender to touch. Fever 101 degrees. Difficulty raising (R) arm. Hives on (R) arm. Symptoms developed the day after receiving vaccines. BENADRYL & MOTRIN for symptoms.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 27Dec2021 (ongoing) (Batch/Lot number: unknown) at 10 mg. Relevant medical history included: "Endometrial Cancer" (unspecified if ongoing), notes: Medical History. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The action taken for lenvatinib mesilate was unknown.  Additional Information: The action taken for bnt162b2 and lenvatinib mesilate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm became very swollen/sore and numb above the elbow by the evening of the administered vaccine and into the next day.  Swelling lasted several days. Numbness still remains to some extent now.
vaccine-associated atrial fibrillation; This serious case was reported in a literature article and described the occurrence of atrial fibrillation in a patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis.    On an unknown date, the patient received Diphtheria tetanus acellular pertussis. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, the patient experienced atrial fibrillation (Verbatim: vaccine-associated atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not reported.   The reporter considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.    The company considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case refers to the patient without age group reported who received DTPa vaccine and had atrial fibrillation. The patient was a part of study which aimed to shed the light on the reported incidence of atrial fibrillation (AF) with different widely used vaccines. The Vaccine Adverse Event Reporting System (VAERS) was used between 1990 and 2021 to search for AF. In this study, the comprehensive evaluation of the incidence of AF in association with all vaccines (COVID, zoster, influenza, pneumococcal, hepatitis B, tetanus, diphtheria, and pertussis (TDAP), tetanus and diphtheria (TD), tetanus toxoid (TTOX), smallpox, anthrax, typhoid, meningococcal, hepatitis A, Lyme, measles, mumps, rubella (MMR), yellow fever, human papillomavirus (HPV), Japanese encephalitis virus, poliovirus, and varicella) was done. The association between the use of vaccines with arrhythmia adverse events was assessed by disproportionality signal detection analysis using the reporting odds ratio (ROR). Total 2341 cases of AF were reported. The patient received tetanus, diphtheria an acellular pertussis vaccine and experienced Vaccine-associated atrial fibrillation.; Sender's Comments:  US-GSK-US2023GSK048793:Same author US-GSK-US2023GSK048184:Same author
FEVER (102.4 DEGREES FAHRENHEIT (F)); TINGLING DOWN THE ARMS, HANDS AND FEET; SEVERE UPPER BACK PAIN (SCALE 9/10); ACHING; NUMBNESS DOWN THE ARMS, HANDS AND FEET; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient was not breastfeeding at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: 30-OCT-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for to prevent of blood clot.  On 08-SEP-2021, the patient experienced severe upper back pain (scale 9/10). On 08-SEP-2021, the patient experienced aching. On 08-SEP-2021, the patient experienced numbness down the arms, hands and feet. On 08-SEP-2021, the patient experienced tingling down the arms, hands and feet. Laboratory data included: Pain scale (NR: not provided) scale 9/10. On 09-SEP-2021, the patient experienced fever (102.4 degrees fahrenheit (f) ). Laboratory data included: Body temperature (NR: not provided) 102.4 degrees fahrenheit (F). Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness down the arms, hands and feet, fever (102.4 degrees fahrenheit (f)), and tingling down the arms, hands and feet on 10-SEP-2021, and had not recovered from severe upper back pain (scale 9/10), and aching. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 at 13:00 as dose 2, single (Lot number: EN 6201), in left arm and on 24Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 30145B19), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Other medical history: Allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after 5 negative days; Positive, notes: Tested positive after 5 negative days. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: patient received anti viral Treatment as Paxlovid. for Covid-19. Start date of treatment is 17May2022 and treatment stop date is 22May2022. Upon follow up product complaint conclusion was added. Conclusion: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to Unknown. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6201, lot EL9262 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. No follow up attempts are possible, no further information is expected.
Inflammation, swelling, pruritic, painful, erythematous area to L upper arm.
Pt was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K). Subsequently the pt tested negative for antibodies. The reporter was wondering if there have been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested.
Day 1 - severe aches and pains and fever Day 2 - moderate to sever aches and pains Day 3 - moderate aches and pains
Nurse preparing the dose got adjuvant on her bare skin; Got adjuvant on her bare skin; Leak came from the stopper at the neck of the vial; Leak came from the stopper at the neck of the vial; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure to product in a 38-year-old female patient who was preparing Herpes zoster (Shingrix) (batch number dc434, expiry date 3rd June 2023) and (batch number 75pez, expiry date 3rd June 2023) to administer in another the patient for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure to product, exposure via skin contact, vial adapter leak and pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure to product, exposure via skin contact, vial adapter leak and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The reporter stated that as contents of Shingrix adjuvant in the syringe were being transferred into the antigen vial, the nurse preparing the dose heard a pop and saw leakage from the antigen vial. The patient did not inject air from the syringe into the vial during preparation. Leak came from the stopper at the neck of the vial. The vial rubber stopper or metallic skirt did not detach or become loose during handling or without any manipulation. The patient removed only the plastic flip-off before handling. There was no evidence of leakage in package or carton. The nurse preparing the dose got Shingrix adjuvant on her bare skin due to the leakage. The reporter did not consent to follow-up. Additional Supportive Information: The nurse preparing the dose got Shingrix adjuvant on her bare skin due to the leakage, which led to occupational exposure to product, exposure via skin contact, vial adapter leak and product complaint.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094958:Same reporter.
This was my 2nd shot of Pfizer on June 11, 2021.  Starting 2 days after injection (around 6/13/2021) I had ~14 days of being very ill with gastrointestinal symptoms including diarrhea and no appetite.  Other people would have gone to the ER and been admitted.  As a former practicing physician, I nursed myself back to health with liquid diet, fluids rest and my own regimen.  It seemed life-threatening at times, but I became better.
suspected vaccination failure; get them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Information has been received from a health professional concerning a 15 yr old white male with attention deficit/hyperactivity disorder who was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06Apr05 the pt developed an itchy rash. On 07Apr05 the pt was seen in the office and diagnosed with post Varicella. Supportive care was ordered. No diagnostic tests were performed. Neither the pt or his siblings experienced adverse events following prior vaccination. There was no product quality complaint involved. Additional information has been requested.
A non-serious spontaneous report of Flu-like symptoms has been received from a 33-year-old female consumer, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
patient reports hives and itching on chin and neck, developing three hours after receipt of vaccine.  Reports that she had blistering rash on back of leg the night after vaccination (states she has had a similar rash in the past, recurring "about once a year."  Reports that hives and itching were worse the morning after vaccination, and that she had "red dots" on neck and scattered on other parts of her body.  Reports she may have had some mild intermittent light-headedness.  Denies swelling of lips/tongue.  Denies tightness in her throat.  Denies syncope/respiratory issues/GI discomfort/nausea/vomiting.  Reports that she did not seek medical attention and did not take any medications for her symptoms.  Reports symptoms resolved on second day after receiving vaccine.
Development of left sided facial Bells Palsy, initially started on Thursday 2/11/2021, symptoms worsened until left mouth and eye droop on Saturday 2/13/21.  Went to Urgent Care on 2/13/21 and received diagnosis of Bells Palsy.  Prescribed Prednisone 60mg daily x 7 days.  Will start today - 2/13/21
One day after the shot a developed a large lump in my left arm bit. The lump was painful. It still has not subsided. I contacted the pharmacy and they knew not of any side affects regarding lumps in the arm pits. I subsequently looked online and read a article talking about swollen lymph nodes. I can?t believe that the people who are given the responsibility of injecting this poison into peoples bodies don?t know the current side affects or have any treatment options other then call your doctor.
Broke out in severe rash/hives. Arms became so swollen; my hands were numb. Had to go to the hospital and be treated with steroids.
Feeling poorly, flu-like. After about a day, I had a headache, sore throat, temperature went up to 101 degrees. The next day I had an extreme sore throat, fever 101.2, o2 sats in the 90's, no shortness of breath. I did the antigen test and it was positive. I felt crummy with headache, moderately sore throat. Worse sore throat I ever had. 02/26/2023 no more fever and symptoms started to subside.
Information has been received from a physician who on 01-DEC-2008 was vaccinated with a dose of GARDASIL vaccine. The patient had an abnormal pap. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 86-year-old male patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives and itchy rash. On an unknown date, the outcome of the hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the hives and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed rash across upper chest which looked like bed bug bites and was very itchy. The patient had hives which was very amorphous in shape, also itchy on arms, legs and buttocks. The patient was not sure if the events related to SHINGRIX or not and they would see a dermatologist later this week. The patient requested to remain anonymous. The patient had denied permission to contact their physician. This case has been linked with US2018178311, reported by same reporter.
Chest pain, shortness of breath, dizziness, headaches, fever, nausea, lethargic. Took to urgent care where an EKG test, mono test, flu test, strep test all completed and were negative. Headaches have been ongoing and random since the first of three injections was administered. Other symptoms happened after last and final injection took place.
I took the Pfizer vaccine on 06/25/21 @ 1:30pm. That night around 10:30pm I felt a painful rush going from my chest to my crouch area, followed by rapid heart beating,  pain in my chest, and difficulty breathing. After standing up and walking for 20 minutes, I fell asleep coming that this would remedy the situation. The next few days I felt persistent dull chest pain, heart palpitations to the point i felt like my heart would explode. And episodes where i felt that i was not getting enough oxygen, rapid heart throbbing, blurred vision, half my face going numb. I went to the ER multiple times and scheduled many doctors visits. Additionally, i feel tingle sensation and aches in my legs, feet, and hands as if they are constantly falling to sleep. I have dull headaches that feel like head sinus pressure in the back of my head, or a sensation of swelling and bleeding. During the first couple weeks these feelings and episodes were unbearable and i am still dealing with them today. Between the feeling my heart beating so strong that it will explode, shortness of breath no matter how hard i tried breathing, needles in my limbs, head aches/brain feeling like its bleeding inside my head or swelling, and half my face going numb during specific episodes I feel as if this vaccine has poisoned me. Its now over a month and I pray to god that eventually these symptoms will stop as it had causes a great disturbance in my life. I think about it every day and it causes stress. I went in to get the vaccine with the best intent, to prevent the spread of covid.
Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with a history of a pap smear on 01-DEC-2006 that was positive for HPV and showed ASCUS, and a colposcopy on 11-JAN-2007 which showed LGSIL, who on approximately 03-JUN-2008 was vaccinated with a first dose of GARDASIL (route and administrating site not reported) at her primary care provider's office. The patient found out she was pregnant about 3 or 4 weeks after receiving the GARDASIL. The patient has a follow up exam scheduled with the physician. The patient sought medical attention by calling the office. The patient's last menstrual period was approximately 21-JAN-2008. The estimated due date is 24-OCT-2008. An ultrasound test perform on 11-JUN-2008 indicated a SIUP at 20 weeks and 3 days. On 26-JUN-2008 a pap smear was negative for HPV. Follow-up information was received from a registered nurse indicating that on 26-JUN-2008 a toxoplasma IgG and IgM was performed with a positive result. Spiramycin was used from 18-JUL-2008 to 11-AUG-2008 for the treatment of toxoplasmosis. The patient's complications during pregnancy included renal failure and alkalosis. On 26-AUG-2008 the patient gave birth prematurely at 31 weeks. The birth weight of the female infant was 1630 gm. Upon internal review the premature birth and the mother's renal failure were determined to be other important medical events. Additional information has been requested.
Complete exhaustion, chills, headache, low grade fever, random muscular pain, pain at injection site, nausea
Rapidly progressive neurologic signs, including paralysis of right leg, pain, bladder and bowel changes, eventually dx as transverse myelitis.
1.15 hour after shot, my chest, throat and nose started to swell up. Based on having had an allergic reaction with first Moderna shot, my allergist had pre-treated me with Prednisone oral steroids, Benadryl and Pepcid so I could get the 2nd shot. The severity and amount of symptoms was less.
Moderna 2/10/21, 3/17/21, 11/3/21. Positive on 1/5/23
Employee reports more than one month after administration that the initial vaccination has caused her to have cardiac complications and is seeing a doctor for this.  No medications or treatment to follow has been ordered thus far. Facility is obligated to report this information as employee states its occurrence.