chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.; he started having pain in the right arm (Injected Arm),; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE JANSSEN (First dose (lot number and expiry date was unknown)); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Second dose. First Monovalent Moderna COVID-19 Booster dose more than 2 months ago (lot number and expiry date was unknown)). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Moderna COVID-19 Vaccine.    On 30-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Dec-2022, the patient experienced VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of Unknown. At the time of the report, INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) outcome was unknown and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional. Patient received 2 Moderna COVID-19 booster vaccine. After the Bivalent booster on 30-Dec-2022, patient started having pain in the right arm (Injected Arm), and can not the lift arm. Patient stated that trying to change gear in the car his right arm hurts. Patient's arm has not improved even with taking Ibuprofen. Patient was on his way to urgent care.   Reporter did not allow further contact
Patient with reddened raised area at site of VARIVAX injection. Approximately 1/2 hour after injection- seen by MD recommended ice and BENADRYL.
Administered vaccination that expired  6 days past expiration date. I did call the manufacturer (Merck) and they said it was supported past label expiration date.
Pt reports woke up the morning after the injection with "puffy face and L side of neck" which turned into a rash. States also had some rash on stomach and R finger which has not lasted as long as the rash on face and neck. States went to ENT for ear infection and he told her it was a "stress rash" and to take BENADRYL. She states arm where she got injection is fine. Pt denies any SOB c the rash, just itching. States not sure she wants to get next injection. Pt will call back with any additional information about the rash
Noticed hardness on 10/13/14 at 2pm. Erythema and swelling w/some streaking 3 days after the pneumonia shot on 10/16/14.
Headache, nausea, tightened sensation in pelvic region (maybe intestinal tract), tingling in both arms, sharp pain in right leg (went away quickly), tired, sore muscles and noticeable persistent blurred vision for about 2 hours so far. I don't feel safe driving and will refrain.   I expected most of these side effects and anticipate that they will go away , but I am troubled by the tingling sensation in my arms and the blurred vision. No one I have talked to has had trouble with vision. I just want to close my eyes and I have to blink a lot to regain focus.
Information has been received from a physician concerning a 16-month-old biracial female with a sulfonamide allergy who on 16-JUN-2006 was vaccinated subcutaneously in the left leg with a first dose of Varivax (lot# 652727/0428F). There was no illness at the time of vaccination. On 26-OCT-2006 the patient experienced chickenpox "despite immunization." No medical attention was sought and no laboratory or diagnostic tests were performed. No outcomes were reported. Additional information has been requested.
I have lot of pain after taking first shot of vaccine and I took; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I have lot of pain after taking first shot of vaccine and I took) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I have lot of pain after taking first shot of vaccine and I took). At the time of the report, PAIN (I have lot of pain after taking first shot of vaccine and I took) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a company representative refers to a female patient currently in her 20's. The patient was vaccinated with an unspecified number of doses of VARIVAX (route, lot number and expiration date not reported) in her childhood (exact date not reported). The reporter stated that the patient was recently diagnosed with shingles. The patient's outcome was not reported. The relatedness between the shingles and the vaccination with VARIVAX was not reported. The patient sought medical attention via phone call. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 984 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Admitted on 12/22 for worwening hypoxia suspected secondary to pulmonary fibrosis exacerbation with right basilar pneumonia. Negative for COVID on admission . Treated with antibiotics and steroids. On 1/1 hypoxia worsened and transferred to ICU with COVID +. Intubated on 1/3. Developed shock, suspecting septic in nature and required increasing pressors. Renal failure with CRRT.  continued with high ventialtory support and continued to worsen overall.
Phone call from parent on 4/15/09 @ 10:15am. She reports child's left arm/shoulder is swollen around injection site. Area, red per report. Mom states she has been giving tylenol. Advised continue with tylenol. Add Cool compress this morning and late afternoon-warm compress. Call MD if no improvement or to see if Benadryl is appropriate to give.
reacted severely to the shingles vaccine (Shingrix) in Sept / suspected Vaccination failure; shingles; nerve pain; joint pain; like lupus my whole back was red and along the nerve pain and joint pain; sick; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus and central vision loss. Concomitant products included hydroxychloroquine (Plaquenil).   In September 2020, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness, nerve pain, joint pain and erythema. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain, joint pain and erythema were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, nerve pain, joint pain and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reacted severely to the shingles vaccine. The patient was sick for 3 weeks almost having shingles and like lupus whole back was red and along the nerve pain and joint pain.  The patient had lupus (autoimmune disease) it was only on skin and after 8 years of being on it the patient had Plaquenil (hydroxychloroquine); toxicity to the central vision loss (permeant).  The patient's immune system was over reactive. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) and on 05May2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "PVC (Premature Ventricular Contraction)" (unspecified if ongoing); "BPPV (Benign paroxysmal positional vertigo)" (unspecified if ongoing); "swollen ankles at time" (unspecified if ongoing); "Animals allergy" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Sudafedrine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. The patient received treatment of Paxlovid for COVID-19 from 16Aug2023 to 20Aug2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288043 Same patient/different product, different dose/event;
swelling at injection site, redness around injection site extending down arm, pain at injection site, itching, fever,  chills, abdominal pain, diarrhea, headaches
Hospitalization: 6/2/2022 admitted; 8/14/2022 discharged.  Presentation to the ED: initially admitted for severe necrotizing fasciitis of her right groin, presenting with complaints of fever chills nausea and vomiting. COVID-19 + date: 07/05/2022. Treatment: treated with IV steroids. Was not given Remdesivir d/t acute renal failure.  Discharge to: patient was discharged to hospice on 8/12/2022 and later became deceased (8/14/2022).
Patient came in 2 days post vaccination complaining of a red rash, inflammation, and skin hot to the touch at injection site. She also had a bad reaction the day after the vaccination that lasted 24 hours including chills, fever, aches, and fatigue but this is common with this vaccintion. Patient was counseled to watch the rash to ensure it did not continue to grow or get worse. Also counseled to take ibuprofen for pain and swelling. Patient cam e in again 4 days post vaccination where the rash has resolved but was still swollen. This was likely an injection site reaction to the vaccine based on resolution but patient still wanted to report side effect to VAERS.
Dizziness; i am getting worst; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea). At the time of the report, DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported.  Patient stated he/she took 1st dose 15 days ago and started to feel dizzy and nausea. Stated that he/she thought temporary but now feeling it would get worst and concerned whether to take 2nd dose or not.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsignificant Follow up appended
Within twenty four hours of having the vaccine I developed extremely painful hives over most of my body.  Not realizing it was related to the vaccine I just took antihistamines to relieve the symptoms which did not help much.  I waited a few weeks before seeing my PCP because knowing I have a soy allergy I made sure anything with soy was removed from my diet to see if that would help but tit did not so at the end of August I went to my PCP who ordered some blood testing and subsequent referrals to an allergist. I was put on a large dose of steroids for about five or six weeks which helped the hives go away but as soon as that treatment was over they returned. Within a few weeks ago that I had to go to the ER with an acute case and was given steroids via an IV. My PCP has referred me to to their physicians but have found no real cure or help I have visited several other Urgent Care facilities for steroid injection that has only been a temporary solution. I continue to take antihistamines and natural supplements to try and manage the symptoms, they are only a temporary solution
Admission for Multi vessel CAD s/p MI and stent placement. The patient was discharged on ASA, statin, and a lower dose of his BB due to soft BPs. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a pharmacist refers to a female patients of unknown age. Medical history and concurrent conditions were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). Concurrent medications were not provided. On 22-OCT-2014, the patient presented to the pharmacy with "a red, 1 inch diameter, circle around the injection site. Pharmacist reported that "there was no raised area or rash present". Pharmacist stated that the patient received the ZOSTAVAX at another unspecified pharmacy. The patient sought medical attention visiting the pharmacy. The outcome of a red, 1 inch in diameter, circle around the injection site was reported as not recovered. Additional information is not expected, because the pharmacist does not wish to be contacted regarding this patient.
This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and gender. The patients' concomitant therapy, medical history, concurrent conditions, drug and allergy history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N002720 and expiration date on 12-MAY-2019 (dose and route were not provided) for prophylaxis. No adverse effects were reported. On an unspecified day, the data logger registered that during 30 minutes, the temperature under the vaccine stored was 47° to 77° Fahrenheit (9° to 25° Celsius), there was previous temperature excursion during 7 hours under the same temperatures. This is one of the two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA001166.
INSOMNIA; WORSE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. 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 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced insomnia. On 06-OCT-2021, the patient experienced worse pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the insomnia and worse pain was not reported. This report was non-serious.
Pt. had lightheadedness and had patches of redness on her chin , neck and cheeks, .  No difficulty breathing and no pruritis noted . On litter in OBs 1 she was C/O her Lt. arm feeling cold and her Lt Hand , at one point she had a metallic taste in her mouth and  " prickely" feeling in her cheeks . She also was shivering when she arrived, That subsided and her face felt hot. Benadryl was offered but refused. Her first vs was 2:28 p-116, resp 20, bp, 166/105 Po2 94%.  She was discharged ambulatory with her husband after her vs stabilized.
Second dose of Arexvy was administered to patient on 10/19/23. Patient thought he had previously received influenza vaccine but had been given an RSV vaccine (Arexvy) on 10/9/23 instead. Patient asked for RSV vaccine and RPh did not double check to make sure patient had not already received the vaccine. No insurance reject. Patient received the second dose and later reported he had found the paperwork from the first RSV vaccine.
Patient is a 62 y.o. male hx etoh cirrhosis and prior varices has been sober for several months who presents with melena. This started last night. In the ER had one episode of coffee ground emesis. Denies chest pain. He is vaccinated for covid, was diagnosed w/ covid 9/26. Has been having myalgias, sore throat, dysgeusia, cough. Denies dyspnea. In the ER he was not hypoxic. Hgb 9.3 which is essentially at his recent baseline. No tachycardia, one BP of 83/51 but subsequently 119/55. Afebrile.
This spontaneous report as received from a physician refers to a 13 years old male patient with asthma and no drug reactions. On 22-OCT-2012, the patient was vaccinated with a 0.5 mL dose of intramuscular GARDASIL. There were no concomitant medications. On the same date almost fell backward, stiffened up, eyes were opened and rolled up for no more than 20 seconds and then the patient was alert. The patient stated that he felt whitish blurry and tired and felt like he was going to go to sleep and could hear but could not get up. The physician stated that the patient had a history of feeling squeamish with seeing blood. Physician stated after the patient received GARDASIL, that he walked out of the room sit in the waiting room and then walked back to the room to get a PPD test. After the purified protein derivative (PPD-turberculosis skin test) was done the patient experienced the adverse events. No further information was available. No treatment was given. The events were considered to be life threatening by the reporting physician. The outcome of the events was recovered on 22-OCT-2012. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
TEMP 103.7 FOLLOWED BY BRIEF UNCOMPLICATED SEIZURE, ABOUT 45 SEC. 911 CALLED, PT EVALUATED AT LOCAL ED, RELEASED.
Initial report received on 21-NOV-2005 from a patient in USA. A 50-year-old male patient with no reported medical history but ongoing head cold or sinus infection experienced injection site pain within an hour following influenza vaccine (Fluzone SV '2005-'2006), lot no: U1865AA administration in the right deltoid. He had received the one dose of the same vaccine previously at an unspecified time. He has pain in the shoulder joint and when he sleeps with his arm over his head, after these 2 and half weeks sore, dull pain in the right shoulder. The patient was not recovered at the time of the report.
Developed a red rash over entire body 2 days after shot.  Feels like a bad sunburn.
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient received the flu vaccine walked out of the immunization room and had a seat. All of a sudden, he felt dizzy and lost consciousness for about a minute and then regained consciousness and started shaking Paramedics were called
about 4 days after receiving the vaccine on 8/23/19 I began having sharp ear pain in L ear  accompanied by very sensitive skin/ear on L side.  I had also had a slight headache that did not go away and felt very tired. Upon going to urgent care for my ear, the PA asked questions that led her to believe that I was pre-shingles and put me on  valacyclovire. Upon taking it the pain was gone the next day.  Then, about  October 24, 2019 I started having sharp pain in my lower jaw and a tooth on my lower jaw and one on my upper jaw became very sensitive to cold and then heat.  I also developed a cold sore (first in 10+ years) about the same time. This continued for about a week (I was out of town at a conference) and upon going to my dentist on 10/31 he took x-rays and examined me and could find no sign of infection or problems.  I was using cold sore medication and as the sore diminished so did the pain.  At the time of both these episodes, my life had become very chaotic and stressful, and as the stress lessened so did the symptoms - particularly the second time since I did not go to urgent care, but was working on the stressors and feeling less stressed as the symptoms were going away.  I never had shingles symptoms before these episodes.