chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 28 year old white female probation officer who on 01DEC2003 at 15:00 was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live at 15:00; SQ in right arm. Prior to receiving the first dose, on approximately 10OCT2003, the patient had a VZV IgG antibody test result of 0.22 (< or = 0.90 is negative with no VZV antibody detected; >= 1.10 is positive with VZV antibody detected). After the receiving the second dose, on 12JAN2004, the pt had a VZV IgG antibody test result of 0.72. The reporter noted that a titer did not show seroconversion. Unspecified medial attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. Additional information is not expected.
162/34 dysautonomia. Influenza virus vaccine, 35 yr old nurse had sudden loss of peripheral vision on left while at work with some numbness in her hands and feet which had been transient since an influenzae vaccine 10/11. She presented to Emergency dept 10/11 and was returned 10/16 for admission. At that time she was suspected of pulmonary edema and was given Lasix. Blood pressure and heart rate had decreased after admission. She had no headache, nausea, vomiting, dizziness. Neurological exam was otherwise unremarkable. CT of the head in the ER was negative for acute change. She was admitted to the hospital with diagnosis of possible scotoma from a migraine without associated headache. MRI/MRA of head and neck obtained at the hospital were normal. Labs were obtained for hypercoag status and were normal. Thyroid functions were normal and she had no further visual symptom after admission. She did have sinus bradycardia and some transient hypotension that was felt secondary to dysautonomia from her vaccine. She was started on Medrol Dosepak just prior to discharge 10/18. The next day pt had tingling and heart rate of 40. Follow up appt's were made with cardiology. Lot U1832BA Fluzone exp 6/30/06. Information from medical record states pneumonia. msv Employee states still has episodes of decreased blood pressure & heart rate
The pt experienced a varicella illness - mild uncomplicated post vaccine on 3/23/00. She developed a zoster rash on 9/7/00 through 9/27/00.
Information has been received from a dermatologist, via an Agency of Observation LLC (Agency reference No. not reported), concerning a patient who was vaccinated with ZOSTAVAX (Merck) (lot number, dose and route not reported). The dermatologist heard about this case from her colleague who had a patient that developed a diffuse case of zoster after the patient was given ZOSTAVAX (Merck) as he/she was immuno-compromized. The events diminished after stopping ZOSTAVAX (Merck). The outcome was unknown. The reporter did not know if the adverse event related to ZOSTAVAX (Merck). The reporting physician considered a diffuse case of zoster to be an other important medical event. No further information is available.
Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, CITALOPRAM, GLYBURIDE, LISINOPRIL, METOPROLOL, CLOPIDOGREL, ATORVASTATIN, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) had not resolved. Not Provided          For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were provided.
Headache, severly swollen lymph nodes, muscle pain, stiff neck, pressure in eyes.
Large swelling at injection site, itching, fever, took OTC Meds and rested, lasted about 36 hrs
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 27-APR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
REDNESS, HARD NODULE AND SEVERE SWELLING,  PATIENT WAS AT URGENT CARE FOR ANOTHER ISSUE AND HAD THE PHYSICIAN LOOK AT HER INJECTION SITE.  THEY TOLD HER IT COULD BE FROM A SKIN INFECTION. THEY DISPENSED ANTIBIOTICS TO HER.
3 days after injection grapefruit sized red reaction local with hard lump and warm to touch. Itchy, did not hurt.
Entire face swollen, including eyes swollen shut. Rapid heart beat, moderate chest pain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-OCT-2009, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 28-OCT-2013, the patient was treated at the same medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Dx Frontal Lobe Seizures 12/5/14 post 24 hr EEG and started on AED's. 7/27/16 dx ESES and Intractable Seizures as seizures are not controlled. Txmt: High dose steroids (IV) 8-29-16 to 8-31-16 to treat ESES (subclinical seizures) High dose IV steroids and high dose VALIUM 11/14/16 to 11/16/16. AED's KEPPRA, DEPAKOTE, ONFI.
Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the event of swollen arm with humira(adalimumab) was no reasonable  Possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sore arm; Face was red; Could hardly walk; Fever of 100.4; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PREDNISONE for Polymyalgia rheumatica.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, Fever, Fatigue and Gait disturbance, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue) had resolved.            Concomitant medication include prednisone.  Treatment medication include Tylenol.  Action taken with mRNA-1273(Moderna COVID-19Vaccine) (intramuscular) was not applicable.
Had a itchy hot rash that spread throughout my entire body for 23 days (lingered longer in some spots but was more manageable). Went to family  doctor, dermatologist, allergist and urgent care. Received a topical steroid and continued to use cold packs to help relieve the pain and itch.
pt feels pinching feeling at injection site. injection site is slightly pink. pt is icing the area, pt will monitor and take advil if needed and keep us updated
Information has been received from a registered pharmacist concerning currently an approximately 78 year old female patient who approximately in 2007 at the age of 65 years was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported). The registered pharmacist reported that on unspecified dates the patient had been hospitalized at least twice for pneumonia. The registered pharmacist would like to know if the patient could be revaccinated four years after the first dose. At the time of the report the outcome of the patient was unknown. No further information is available.
lymphadenopathy and erythema on the right side, which was the right of the injection; lymphadenopathy and erythema on the right side, which was the right of the injection; erythema around her arm, the injection site/It was swollen; erythema around her arm, the injection site/It was swollen; This is a spontaneous report from a contactable Other Health Professional (Specify as Anesthesiologist, also the patient). This is the second of 2 reports for dose 1 and dose 2. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in Arm Right on 23Dec2020 (Lot Number unknown) at the age of  61-year-old, and dose 2 via an unspecified route of administration in Arm Right on 13Jan2021 (Lot Number unknown) at the age of  61-year-old, for Covid-19 immunization. Medical history included scoliosis; pain. Concomitant medications included pregabalin (LYRICA) taken for scoliosis; diazepam (VALIUM) taken for scoliosis; ibuprofen taken at night for the pain help to relieve pain; calcium; amlodipine (AMLODIPIN); baclofen; ibuprofen (MOTRIN), multivitamin (unspecified), and "Xytone" (unspecified). Due to scoliosis, the patient was taking LYRICA and VALIUM which sort of kicked up in getting a 3rd vaccine. Also stated it was her Second vaccine on 13Jan2021 so, she was 8 months out. Also stated that she thought aphrodisiac (Not clarified). No prior vaccination ever in her life. It was reported that, she got her 3rd dose because she was on various medicines. On last Thursday and Pfizer so, The 1st two, anyway, what happened was that, she got lymphadenopathy and erythema on the right side, which was the right of the injection. She also had erythema around her arm, the injection site, that hasn't changed that was about like, it was like 3 into 5 inches. It was swollen and she had that 2 times, The 1st two times.  She had not had the swollen Adenopathy so. The outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax 29MAR96 & 3MAR98 pt devel chickenpox that consisted of more than 200 lesions;pt was treated w/DPH;
Patient admitted on 1/16/22 with acute metabolic encephalopathy secondary to UTI and COVlD-19 pneumonia with associated acute hypoxic respiratory failure after she presented to the Emergency Department with altered mental status and generalized weakness.  Her weakness was growing progressively worse so that she could no longer get out of her wheelchair and use a walker as she had been able to do a month prior. In the Emergency Department, her urine showed evidence of infection, so she was given IV Rocephin. CT head showed severe atrophy without acute findings. CT abdomen/pelvis was negative for acute abdomen, but did show evidence of COVID-19 in her lungs. It also showed that her abdominal aortic aneurysm had grown to 4.9 cm. The patient was febrile, WBC was 11,200, and lactic acid 2.7. COVID-19 test was positive.  The patient developed hypoxia, and so received supplemental oxygen, JV dexamethasone, Rocephin, and azithromycin.  The patient was noted to have a wound on her right foot. It was unclear how long It had been present. After the wound therapist debrided the wound, she found exposed bone. An arterial ultrasound was ordered to evaluate how well the wound could heal. She was noted to have significant peripheral arterial disease on the right lower extremity ultrasound. Vascular Surgery was consulted and performed an arteriogram on 1/28/22. Per the Vascular Surgeon, findings showed "Occlusion of the left common iliac artery with no flow seen distal to it.  Her family was updated on her condition, and decided to make her DNR/comfort cares. The patient died on 1/29/22 at 1044 with family by her side.
10MAR98 c/o h/a & stiff neck, T101.4;
A first dose / was given Sub q; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 details provided were as follows: Age at vaccination was not reported. The nurse reported that, the patient received 1st dose of Bexsero subcutaneously which led to intramuscular formulation administered by other route. The reporter did not share any other information. The reporter did not consent to follow-up.
In October 2022 I suffered severe diarrhea and constipation. The medications that they gave me to help caused issues with my sodium. I was diagnosed with EPI, Exocrine Pancreatic Insufficiency, a pancreas disorder. I had inflammation in my gut and excess mucus in my digestive track. I am not taking Creon. I had some upper respiratory symptoms in late October with scratchy throat and fatigue. I then was treated for a sinus infection in early November and prescribed Z-Pack and Azithromycin. After this I had issues with my blood pressure and then the upper respiratory symptoms returned. I was still having diarrhea and constipation that continued through today. We continue to monitor and try medications. I have also been diagnosed with irritable bowel syndrome.
I received my flu shot in my L arm. Upon receiving it, I felt a very odd sensation that went away once the needle was removed. The nurse thought she may have injected too close to my shoulder joint and hit a bone with the needle. I didn't think much of it at the time. A couple days later, I developed shoulder pain. I did all my "therapy interventions" without improvement. It's been 2.5 weeks. I have shoulder pain, decreased shoulder ROM, and shoulder weakness with certain movements. I am concerned that I experienced SIRVA as I have not had any other injuries.
Sore throat; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 77-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 16-SEP-2023, the patient received RSV vaccine. On 17-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced sore throat (Verbatim: Sore throat).  The outcome of the sore throat was not resolved.   It was unknown if the reporter considered the sore throat to be related to RSV vaccine.     It was unknown if the company considered the sore throat to be related to RSV vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 The patient reported him-self. The symptoms was not treated. The reporter consent to follow up by email.
pt recvd vax 16AUG95 & 15AUG95 pt was seen by MD for OM & placed on Amoxicillin;24AUG95 pt exp fever, febrile sz & was haspitalized;spinal tap was neg & WBC was 19,500; pt recovered;
Rph  found  that   the  given  Vaccine  has  expired a week  before  the  administration.  Pt Contacted, and  confirmed  no  adverse  event  occured.
6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder to elbow & headache, chills, tool Tylenol.  No appetite, very loose bowels at 10:00 am, (NOTE: NO fever)  headache, chills continued all day & dizziness was added only when I moved my eyes like to glance at something or trying to read . Woke up, all symptoms were gone except a little swelling around injection site. 48 hours after injection, only very little swelling at injection site.
Pt had seizure (new onset) 19 Apr 2009. After extensive work-up there is no indication for an underlying cause. Pt concerned that seizure developed as a result of ANTHRAX vaccine.   8/4/09 Hospital records received DOS 5/29/09. Assessment: Seizure epileptic. Patient had 2 witnessed seizures and was transported to ER. Confused (post-ictal), lethargic, dehydrated. Shaking all over. Nausea, vomiting. Incidental skin infection.  ICD-9 Codes: 345.90  Epilepsy without mention of intractable seizures.  8/17/09 Hospital records received DOS 4/18/09 - 4/19/09. Assessment: Trauma Patient brought to trauma center after motocycle collision. Was wearing a helmet, combative at scene, seizure-like activity, loss of consciousness, endotracheal tube placed in the field.
6 mo Male developed hives after adm of Pediarix, PCV7 given Benadryl 1/2 tsp.
pink hard bump about 1.25 - 1.5 inch in diameter; Tenderness; got subcutaneous injection and not intramuscular; ran out of syringes, so they started using insulin syringes for which needle is very short; A spontaneous report was received from an other healthcare professional (HCP) concerning a 49-year-old, female patient, who experienced inappropriate route of product administration , tenderness, pink, hard bump about 1.25-1.5 inches in diameter/erythema induratum, and insulin syringes used/wrong technique in product usage process.  The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Zyrtec, Qvar inhaler, Nasacort inhaler.  On 09 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Mar 2021 the patient thought that she got the injection  through sub cutaneous route instead of intramuscularly.  The patient had been to clinic . The pharmacist said they ran out of syringes. So they started using insulin syringes for which needle is short for subcutaneous  injection use. She experienced tenderness on 9 Mar 2021 and on 10 Mar 2021 raised pink hard bump about 1.25  1.5 inch in diameter.   Treatment of these events were not reported.  The outcome of the events, inappropriate route of product administration and wrong technique in product usage were considered recovered/resolved.  The outcome of the events, tenderness, induration erythema were unknown.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot #013A21A  with associated Adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I got the shot in my left arm at about 3 PM on March 18th. I did not have any side effects within the 15 minute waiting time. After 2 hours my arm became very sore and throbbing. I took 1 regular aspirin and 1 extra strength Tylenol. I went to bed at around 10 PM. I woke up at 3:30AM on March 19 gasping. My upper throat was tight and seemed to be spasmodic. Suspecting that it was an allergic reaction, I took 1 Benadryl tablet. I had difficulty swallowing the medication. After about 1 hour, where I was not seeing any improvement, I decided to go to ER .  They took two Soft tissue X-rays of my throat.  They gave me a nebulizer treatment with a bronchodilator racepinephrine at 7:05AM March 19. At about 8:15AM they gave me a steroid pill and I left the ER at 8:21AM.
Information was received from a licensed practical nurse referring to an 18 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 09-AUG-2018, the patient was vaccinated public funds at a private doctor's office/hospital with improperly stored doses of VAQTA (lot # R006210, expiry date unknown) and MENACTRA (lot # U5917AA, expiry date unknown) intramuscularly in the left deltoid and VARIVAX (lot # R002051, expiry date unknown) subcutaneously in the right arm for prophylaxis. The patient previously received one dose of VARIVAX. No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007644.
My 3-year-old daughter was highly verbal and speaking in complete sentences. She received the flu shot and began stuttering two days later, though it was just first syllables and occasionally at that time. The next day the stutter is on almost every single word to the point that she can hardly get through her sentences.
A pharmacist reported that a male child received his 1st dose of Prevnar and 48 hours, post vax, he developed shortness of breath and was taken to the ER. No further information was available as of the date of this report.