chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; Tired; Achy; Right arm was sore; Sudden eye floaters; There were floaters in her eyes described as "black spidery floater" moving around her eyes.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0196) via an unspecified route of administration, administered in arm right on 24Jun2021 15:15 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization at clinic. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0178) via an unspecified route of administration, administered in arm right on 03Jun2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization and experienced sore/achy arm for about 24 hours and ice helped. The patient previously took morphine [morphine sulfate] and compazine [prochlorperazine edisylate] and experienced allergic reactions. Patient reported that she had medical reactions to different medications. On 24Jun2021 at 16:00 (within an hour of vaccination), patient right arm was sore and there were floaters in her eyes described as "black spidery floater" moving around her eyes and was definitely changed the perception out of that eye. "One big floater is kind a dark not easy to spot. On 25Jun2021, it was reported that patient was tired and achy and on an unspecified date patient had cough. None of the AE require a visit to emergency room or physician office. Patient was asking if there were reported similar reactions after the second dose and if so, is it something that gets away quickly and was asking if this will dissipate soon or should she see her eye doctor. Further stated that she looked up generic side effects online and it is mentioned in different places. The outcome of the events vitreous floaters and eye disorder was not recovered whereas, outcome for remaining events was unknown.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a physician referring to a 5 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 09:00 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Dizzy became worst; Weak became worst; Not able to do anything and could not drive car; pain moved to his left arm soon after the vaccination became worst\  pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 212A21A and 012A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg). At the time of the report, DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg) had not resolved. Not Provided          Treatment information not provided.  Concomitant medications were not provided.  The symptoms became worst after the second shot.  In followup patient stated that the event-Still having excruciating pain in left leg and also stated that  Wrecked a car since getting the vaccine.   This case was linked to -MODERNATX, INC.-MOD-2021-060819 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains significant information, updated  I-narrative.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-060819:dose 1
Almost immediately, felt achy right away Fri AM 2 1/2 to 3" rash - arm swollen all the way to the shot was, developed a large hard, reddened and hot to the touch for 7 days. Body aches and low grade fever - lasting 11 days.
I started feeling nauseous and a little dizzy right after the shot. That continued the rest of the evening. The next day, I had an awful headache that wouldn?t dissipate with Tylenol. I also started getting the chills really badly. Later in the evening I became very hot as if I had a fever. I believe that fever broke over night. The next day I just still felt under the weather. The following day, I noticed I had painful swelling down my armpit and into my breast area. It felt like it was kind of going down the lymphatic area. It was only on the left side, which is where I had my shot. The left arm has been severely sore since the shot was given.
Violent hallucination; Diarrhea; Rash; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (Violent hallucination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ALPHA-1-ANTITRYPSIN (ZEMAIRA) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) 1 dosage form. On 23-Mar-2021, the patient experienced HALLUCINATION (Violent hallucination) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting). On 28-Mar-2021, HALLUCINATION (Violent hallucination) had resolved. At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) was unknown.       Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.
This is a literature report from the Regulatory Authority, 2021, vol 32; pp 842 entitled Utilization of donor-derived cell-free DNA and total cell-free DNA to inform treatment decisions in a pancreas transplant recipient with COVID-19 infection and active rejection.   A 51-year-old female received a deceased donor pancreas transplant in Aug2020. The patient was maintained on a triple immunosuppressive (IS) therapy regime, had stable amylase and lipase levels and no episodes of rejection. Six months later, the patient received the first dose of a COVID-19 vaccine, and the second dose three weeks later. The patients spouse was diagnosed with COVID-19 and soon after, the patient had elevated pancreatic enzymes, 156 and 199 (prior labs 67 and 27) and presented with elevated temperature (100.4 F.), cough, fatigue, loss of taste, diarrhea, myalgias and rhinorrhea. The patient was determined to have COVID-19 with a severity score of 2. IS was reduced and monoclonal ab therapy was initiated. dd-cfDNA fraction was 1.38%, indicated high-risk for AR, with corresponding total cfDNA elevated 10.2 multiples of the median (MoM). The patient was treated with Methylprednisolone 500 mg with a PO Prednisone tail. Three weeks later, the patient was negative for COVID-19 and IS was resumed. The dd-cfDNA fraction at this time was 1.59%, and total cfDNA decreased to 1.1 MoM. Subsequent weekly Prospera tests indicated dd-cfDNA fractions of 1.03%, 0.54%, and 0.81% with total cfDNA levels of 1.4 MoM, 1.3 MoM, and 0.94 MoM. Measurement of dd-cfDNA can guide IS management in pancreas transplant recipients with COVID-19 undergoing AR. Viral infections and anti-rejection therapies can influence total cfDNA. Thus, continued monitoring of both total and DD cfDNA are needed to identify a true response to therapy.; Sender's Comments: Based on the available information, a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported events COVID-19 and vaccination failure cannot be excluded.
About three hours after started running a temperature and general body aches, chills. That was a Saturday and could only get it down to about 100 degrees. Symptoms cleared up by the following weekend. Called PCP on Sunday and spoke with them on Monday but was told he was just going to have to deal with it and it was normal.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (Strength, dose, frequency, route and anatomical location were not reported) of lot/batch # N011491 with an expiry date of 04-NOV-2018, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number N011491 has been verified to be a valid lot number for PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA007255: US-009507513-1708USA007256:
Terrible felling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Terrible felling) and PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Terrible felling) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Terrible felling) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Patient arrived at clinic 4 days after tetanus injection stating that he had SOB and weakness, dizziness from tetanus shot. He also noted that his left arm was swollen, and RN who examined him noted, that the left deltoid was slightly larger than the right, but no redness or inflammation was noted. Vitals taken were all WNL. RN recommended ice, elevation, rest, and OTC ibuprofen or ADVIL. Another RN followed up with patient and patient noted that he was a lot better.
I was given flu shot on 09/11/2012 at 03:20PM. After flu shot was given, in the early morning about 5:30am, on the 09/12/12, I felt so dizziness, I could not walk because unbalance walking. It has been continuing happen to me for 04 days. I went ermergency at hospital. I had stay there about 02 hours. I was given one tablet Meclizine. Then doctor released me to home. But the dizziness continued happen to me until now. I need help for treatment. But I don't have health insurance or medical that coverage.
This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Left leg red, swollen, warm to touch, 7 x 7cm in size.
Complained of itching - mainly on legs, starting 2/17/12.  Er 2/18/12, PCP 2/20/12, dermatologist 2/21/12.  DX:  erythema multiforme.  Using steroid cream, improving.  Rash did spread to rest of body.
The day after the vaccine, 02/23/2021, I had the swelling, it was getting big, slightly itching and it got worse and worse and red and hot. The red covered the top part of my arm. I kind of have a darker skin tone there as of now. It could just be just my age. Within after a week, I went to see my doctor. He said he had seen a few after the vaccine. And he prescribed cortisone and Benadryl. It took 2 weeks for it to go away.
This case was reported by a consumer via call center representative and described the occurrence of poor sleep in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced poor sleep. On an unknown date, the outcome of the poor sleep was unknown. It was unknown if the reporter considered the poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. At 14:15 hours, the patient received SHINGRIX. The patient did not sleep well the night after receiving the SHINGRIX.
Bell's Palsy 9/15/09. Steroid, VALTREX, acupuncture treatment.
aching of entire body night sweats nausea some chills every day since vaccine was given began the evening of the vaccine.
On 5/29/00, the pt began running a temperature of 103, she had bloody diarrhea. She went to ER due to severe cramping. Dx with intussusception. Surgery was performed on 5/30/00. Stayed in hospital until 6/1/00. She was still having bowel problems on 6/14/00.
Scratching/rubbing it produced a rash.; She felt intense itchiness on injection site; Scratching/rubbing it produced a rash/Rash s still present and worsens upon itching; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratching/rubbing it produced a rash.), VACCINATION SITE PRURITUS (She felt intense itchiness on injection site) and RASH (Scratching/rubbing it produced a rash/Rash s still present and worsens upon itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and GLIPIZIDE for an unknown indication.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced RASH (Scratching/rubbing it produced a rash/Rash s still present and worsens upon itching). On an unknown date, the patient experienced SCRATCH (Scratching/rubbing it produced a rash.) and VACCINATION SITE PRURITUS (She felt intense itchiness on injection site). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOCAINE HYDROCHLORIDE (NEOSPORIN + BURN RELIEF) at an unspecified dose and frequency. At the time of the report, SCRATCH (Scratching/rubbing it produced a rash.), VACCINATION SITE PRURITUS (She felt intense itchiness on injection site) and RASH (Scratching/rubbing it produced a rash/Rash s still present and worsens upon itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports that on 03 JUL 2021, she felt intense itchiness on the injection site and upon scratching/rubbing it produced a rash. The patient claims that the rash is still present and worsens upon itching.
At 1:00 AM chills, fever of 101.2, body aches, extreme Migraine,  extreme fatigue, could not move upper arm away from my body (Sever left arm muscle pain, for two and a half days after the first vaccine.
Pruritic rash on face and chest. Also weakness, fatigue, and body aches. Benadryl 50mg given orally.
Headache, arm pain, sleepy and very tired also I had a really bad sore throat very read and painful.
Information has been received from a physician concerning an 11 year old female who on 19-MAY-2009 was vaccinated with the second dose of GARDASIL (LOT# 661841/0653X, route and site of administration not reported). The patient experienced dizziness after getting the second dose of GARDASIL and about 4 to 7 hours later she became tachycardia up to 150 that stayed for 2 or 3 days. She received the first dose of GARDASIL (LOT#, route and site of administration not reported 0.5ml) on 19-MAR-2009 with no adverse event. The outcome of dizziness was unknown. Follow up information has been received on 29-MAY-2009. It was reported by the office manager that on 19-MAR-2009 the patient received the first dose of GARDASIL (lot#661952/1129X), VAQTA (lot#662532/1584X), ADACEL (lot#UF452AA) and MENACTRA (lot#42870AT). On 19-MAY-2009 the patient went to the Emergency Room for some unspecified medical attention. In additional follow up the responsible physician stated that the patient was not admitted to the hospital. The patient's EKG revealed Sinus Tachycardia, heart rate 140 to 150. The tachycardia lasted for one day. The patient's dizziness and tachycardia resolved. The patient was referred to cardiologist. The patient had an appointment at the vaccinating physician's office on 26-MAY-2009 and the patient was completely normal. It was reported that the patient was scheduled for the third dose of GARDASIL in 3 and a half months. No further information is available. The patient was treated in the emergency room at hospital.
12/11/2022 Woke up with sore throat.  12/12 Tested with an At Home COVID-19 test, positive.  Fever peaking at 103.5, coughing, chest pressure, and body aches started that day. Telehealth with doctor who proscribed Paxlovid, cough syrup, and prednisone for after Paxlovid.  Fever broke 12/14, symptoms improved.  Pulse Ox dipped as low as 95 while this was happening.  12/15 Diminished cough and other symptoms.  12/26 things returned mostly to normal, but cough, fatigue, and congestion lingered with the occasional body pain.   3/2 Another round of Covid appeared.  Symptoms were the same, but less severe with lots of sneezing.  Fever peaked at 101.  3/3 tested positive on At Home COVID-19 Test.  Televist with doctor who proscribed just Paxlovid this time.  Second bout Mostly resolved my 3/10, with just lingering fatigue at time of reporting.
Vertigo, dizziness, fingers numb/tingly, while walking legs collapsed/weak, double vision, nausea
Janssen COVID-19 Vaccine EUA Chills, trembling, dizziness, ringing in ear started at 5:30PM and  gradually increased into the night and subsided at around noon the following day Intense joint pain throughout body lasted all night and subsided in about a week Sharp left knee pain lasted for 3 days Headache last for 24 hours Took two Advils for the pain, but that did not help.
According to student + confirmed w/Dr. Varicella shot was given in (R) Volar aspect of arm. Patient had a red raised reaction measuring 4 inches wide by 3 1/2 inches long. Varicella shot should only be administered SQ in lateral aspect back of arm + outer thighs per package insert.
Case number PHEH2014US018762 is an initial spontaneous report received from a nurse on 17 Sep 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), intramuscularly reconstituted with a sterile water instead f MenCYW-135 liquid component on 13 Sep 2014. No adverse reaction was reported following this administration error.
Caller received the first vaccine April 30, 2019. / did not receive the second vaccine.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly on unknown date, batch number-2Y9R4, expiration date-28th June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe