chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt consented to 2nd  vaccine . Stated that she had swollen legs for 2weeks post vaccine, saw PCP. He recommended that she get her 2nd vaccine, did not believe it was related to receiving  vaccine. Vaccine was given by vaccinator soon after pt became non verbal, would not respond to her name. Pt was brought to EMS tent. Vitals recorded and stable. See EMS note for vitals. Pt was given 4L of  O2 became verbal and responded to commands appropriately and was A+O.X3  EMS director recommended pt be transported t0 hospital.  Pt agreed to go to ER and was sent via ambulance
Tinnitus. Symptoms started at night of the 2nd or 3rd day after the shot. The buzzing was so loud it made it hard to sleep. The buzzing continues throughout the day but it seems less loud possibly because of other sounds. It?s worse at night when it?s more silent. For over 3 weeks they were constant after which I had another dose and they started again. About 4-5 weeks after the second dose the ringing/buzzing lessens in volume and frequency, until now when I get it about 3 days a week, especially noticeable when I?m in silence/ away from noise whether at night or not. The buzzing is a great deal less than it was up into June/July of this year, but it is still there.
renal disorder nos; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (renal disorder nos) in a 62-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (renal disorder nos). At the time of the report, RENAL DISORDER (renal disorder nos) outcome was unknown.            No concomitant medications reported. No treatment reported  Patient reported that he had two, without symptoms, and is concern of getting the third. Procedure do to he had major surgery and doesn't want to contract. Two major surgery related to his kidney, and doesn't want to get infected.
On 26 February 2001, the vaccinee received her first left deltoid "adult" dose of Engerix-B. Post-vaccination, on 26 February 2001, the vaccinee experienced numbness and cold sensation in her left arm. As of 6 March 2001, the outcome of the events was resolved.
Breakthrough case of COVID after fully vaccinated.  Tested positive at urgent care 7/31/2021.  Received  8/2/2021
Use of Kinrix for a child who is age 7; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-Sep-2022  Reporter's comment: The reporter asked a question that was there any efficacy, safety data or post marketing information on the use of Kinrix for a child who was age 7?  The sales representative confirmed the label of Kinrix was through the age of 6 years but customer was requesting information on the question above.  The sales representative had been unable to get confirmation if there was a medical error that had already occurred in this 7-year-old patient.  It was unknown at this time if Kinrix was indeed administered to the 7 year old.  The reporter consent to follow up. Additional Supportive Information: The seven years old patient was given Kinrix, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR218071:Same reporter
FLUZONE HD was administered to patient of less than 65 years age, no AE; FLUZONE HD was administered to patient instead of FLUZONE Quadrivalent, no AE; FLUZONE HD was administered to patient of less than 65 years age, no AE; Initial information received on 09-Nov-2021 regarding an unsolicited valid  non-serious case received from a physician via the Agency (under the reference number 00850043).  This case is linked to case 2021SA378207 and 2021SA378956 (cluster).  This case involves a 15 months old female patient who was below 65 years age and was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age) (wrong product administered) (overdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date (was unable to obtain), the patient received 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once in total, lot number UJ773AC and expiry date: the caller did not have this information available) via intramuscular route in the left leg for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was also a case of overdose (same day latency).  It was reported "Physician called to report that she ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead. The FLUZONE HD was administered to three patients less than 65 years old before she realized it was FLUZONE HD. Adverse Events were reported for all THREE patients with as much information as the caller was able to provide. The caller was in a hurry to obtain/provide information and return back to her practice."  The physician was unaware of any treatment, emergency room (ER), or Doctor (DR) visit necessary post administration at the time of the call. At time of reporting, no adverse event 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 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.
Pt came via EMS with SOB, Ronchi lung sounds, and SPO2 84% RA. Chest x-ray was performed demonstrating mild patchy bilateral opacities correlated with known COVID-19.  view of these findings, it was decided to admit the patient for further treatment of COVID-19 and hypoxemia.
Patient received DTaP, MMR and VARIVAX flu on 03/07/08 and had a febrile seizure 3/16/08.
large red, hot, hard area at injection site, 3 day ( severe diarrhea, vomiting, fever, freezing cold chills, very weak)
My heart has been pounding hard with some pain. Shortness of breath. Coughing. Pain in left chest. Breast bone hurts
I did not have a reaction to the vaccine. On 12/03/2022, I started not feeling well with fatigue and congested sinuses. On 12/05/2022, I tested positive for COVID-19 with a home test. I contacted my doctor and was prescribed PAXLOVID. On 12/07/2022 I had to get an antibiotic and steroid prescriptions for a sinus infection.
ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEATING UP AND TURNING RED.   I TOOK A BENADRYL AND IT HELPED A LITTLE.  SUNDAY THE SHOT SITE STARTED TURNING RED AND WAS SWOLLEN A LITTLE LARGER THAN A QUARTER.
Information has been received from a pharmacy nurse concerning a female who on 20-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On 25-JUL-2007 the patient notified the nurse about a rash on her abdomen. The patient was instructed to follow-up with her primary doctor. Unspecified medical attention was sought. The outcome is unknown. No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information is not expected.
24mins post vaccination, pt c/o dizziness and "body shakes".  Vitals: @14:00 BP 102/71, HR 78, Temp 98.2F, SpO2 100% -- > @14:17 95/67,78, 98F, 100% -- >@14:27 95/62, 70, 97.7, 100%. Brief Exam General: Awake, alert, conversing comfortably. Intermittently heavy breathing HEENT: No evidence of lip swelling or angioedema CV: RRR RESP: CTAB, no stridor, wheezes, no signs of increased WOB DERM: No visible rashes   Patient notes her breathing is "slightly different than usual" and some nausea but no lip swelling, tongue swelling, throat closing, stridor, emesis, rash, angioedema. Patient was monitored in observation area for additional 30 minutes. She was noted to be shaking due to the cold so was brought outside. While outside, was able to walk around and drink another bottle of water. She endorsed feeling better and much less dizzy and she was discharged home. Available to drive her home.
(Moderna) Vaccine was given beyond the refrigeration use; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. On 02-Jun-2022 vial was initially stored in the refrigerator and vaccine was administered on 07-Jul-2022. It was reported that patient received first booster dose. The vial does not undergo any temperature excursions. Treatment details were not reported by the reporter.
arm pain especially when lifting his arm; malaise; This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. In approximately 2017 (reported as 2 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for unspecified chronic condition. On unknown date in 2017, the patient experienced arm pain, especially when he was lifting his arm and malaise. The outcome of events was reported as recovered within one week of the administration. There was no causality assessment provided by the reporter.  This is one of several reports received from the same reporter.
My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue.
Numbness; tingling and swelling of my lips; tingling and swelling of my lips; Sensation that the skin around my eyes and cheek bones was being stretched/weird feeling/ everything was going in slow motion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: 3303080) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing); "Allergies: chicken" (unspecified if ongoing); "Allergies: Egg" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, reaction(s): "Allergy: Flu shot". The following information was reported: HYPOAESTHESIA (non-serious) with onset 19Nov2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA ORAL (non-serious), LIP SWELLING (non-serious) all with onset 19Nov2021 10:00, outcome "not recovered" and all described as "tingling and swelling of my lips"; FEELING ABNORMAL (non-serious) with onset 19Nov2021 10:00, outcome "not recovered", described as "Sensation that the skin around my eyes and cheek bones was being stretched/weird feeling/ everything was going in slow motion". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia oral, lip swelling, feeling abnormal. No follow-up attempts are possible. No further information is expected.
Local reaction, rash -> swelling - blister after about 10 day. Scar depressed "like chicken pox usually do" with hard border (by father's description).
This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8738), at the age of 42, via an unspecified route of administration, left arm, on Apr 25, 2021, at 19:30, single dose, for COVID-19 immunisation. Medical history included diabetes and high blood pressure. Concomitant medications included diabetes medications. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 26, 2021, at 00:00, patient's left arm hurt. He experienced fatigue and throwing-up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. On an unknown date, patient underwent COVID-19 test (nasal swab), and the result was negative. The outcome of left arm hurting, fatigue and throwing-up resolved on an unknown date in 2021. No follow-up attempts needed. No further information expected.
patient passed out.  when awoken was clammy and sweaty.  Lowered him to the floor where he complained about being hot and cold alternatively.  BP was usually low 110's over 60 pulse ran about 56.  Patient was nauseas.  Used ice packs to cool him, and towels to warm him.  He did not vomit.  He continued to be dizzy and sweaty.  BPs and pulses did not improve, after 40 minutes of symptomatic treatment, he consented to an ambulance being called.  He was treated by paramedics, I do not know if he was taken to the hospital.
6OCT92 7PM became quite lethargic became mottled from forehead to hairline; had cyanosis; temp on admit to ER 99-30 mins later 102 gave APAP in ER;
INDIVIDUAL RESTARTED PRIMARY SERIES OVER BECAUSE THEY DID NOT RECEIVE THE 2ND DOSE WITHIN 21 DAYS.  NOTIFIED FACILITY THAT 2ND DOSE IN SERIES CAN BE GIVEN AT ANY TIME AFTER 21 DAYS AND THAT YOU DO NOT NEED TO RESTART SERIES.  NO ADVERSE EVENTS REPORTED.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-MAY-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 1728 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
p/vax pt exp fever, chills & severe pain in inj site arm;pt w/fever & intermittent chills;T100 tympanic;also cough, body aches, fatigue & feeling dry;blood & leucocytes in urine & urine cult showed E-coli >100,000;tx w/cipro & keflex;
Numbness on left side of face. Headache, watery eyes, dropping left side of mouth.
Rash at injection site and warmth at left deltoid muscle to touch.  Diphenhydramine and Ibuprofen 3 times a day, helped it subside.
Pt called two days after injection (12/6/17), regarding concerns. Call placed to patient on 12/7/17 to discuss concerns. Pt returned call on 12/11/17 stating pt had localized redness and swelling at injection site, but at this time it had resolved. Pt describes no other symptoms. Discussed with provider, no actions taken.
Malaise, aching in joints (comes and goes), rash on forearms, headache, "flu-like".
GOT SICK TWICE; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; This spontaneous report received from a parent via social media concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 21-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date after vaccination, it was reported that the vaccine shot had made the patient sick twice. On 19-JUL-2021, the patient tested for covid-19 and the result was positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive, got sick twice and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186589 The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation.; Sender's Comments: V0; 20210743654-COVID-19 VACCINE JANSSEN-Suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
4/5/21 - Shot  4/6/21 - flu like symptoms 4/6/21 - persistent headaches & pains in body start (pains vary - some shooting some persistent) 4/9/21 - primary care does D-Dimer Test (result 1.46) 4/10/21 - primary send me to ER 4/10/21 - ER does blood work & EKG, all fine.  Checks out AMA w/o CT scan. 4/17/21 - Bruise appears between eyes and above nose w/o any trauma event. 4/17/21 - checks back into ER.  Blood work fine, CT scan fine. 4/18/21 - headaches and body pain continue to persist (most notable body pain is almost a numbness feeling in legs and arms at joints) 5/11/21 - headaches have subsided partly but numbness body pain persist.
Vaccine hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Vaccine hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 29-APR-2023 This case was reported by a patient via interactive digital media. The patient's friend got shingles in her head, it had been 3 years and she was even suffering with that right now and they had to remove a piece of brain. The patient stated that the vaccine hurts but it was very effective. The follow-up could not be possible as no contact details were available.
Red patch 10cm x 10cm Rt deltoid. Itching but no induration or swelling. Afebrile.
PATIENT HAD SWOLLEN LYMPH NODES, HIVES, BLISTERS, FEVER AS HIGH AS 104.
This case was reported by a consumer via call center representative and described the occurrence of chalazion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included scab. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 15 days after receiving SHINGRIX, the patient experienced chalazion. On an unknown date, the patient experienced eyelid pain, eyelids pruritus and cyst. SHINGRIX was discontinued (Dechallenge was positive). On an unknown date, the outcome of the chalazion and eyelid pain were recovering/resolving and the outcome of the eyelids pruritus and cyst were recovered/resolved. It was unknown if the reporter considered the chalazion, eyelid pain, eyelids pruritus and cyst to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient received SHINGRIX on left deltoid. The patient stated that she did not have any discomfort, pain, or swelling, but within days, her left eyelid had soreness and the root of her eyelash started to itch. By 17th May 2018, the patient had a big bump there and she saw her ophthalmologist on the 18th May 2018 and he diagnosed her as having a chalazion cyst and informed her to use hot compresses on it and to return in a week if it did not go away. It did not go away and the patient had to have a procedure where they cut and cleaned out the area. On 8th June 2018, the patient had begun to have the same symptoms in the right eyelid area that resulted in having the same procedure on 5th July 2018. The patient's ophthalmologist recommended that she had to see her internist when her right eye became involved to make sure it was not anything systemic, as the ophthalmologist felt that it was unusual to have the same occurrences in both eyes, in exactly the same place. The ophthalmologist's internist tested the patient and ruled her out for diabetes, staph and cholesterol related issues. On 17th July 2018, the patient was due for her 2nd dose of SHINGRIX, but her pharmacist did not feel comfortable administering it, so she had not received it. The patient stated that, her both eyes were healing, but there are scabs there from the procedures on the reporting date. The patient stated that at first she did not associate her incidences with the vaccine, but began to look at the timeline in addition to ruling out other causes, and thought that they might be indeed associated. The patient had given permission to contact their physician.